[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 830 Reported in Senate (RS)]





                                                       Calendar No. 105

105th CONGRESS

  1st Session

                                 S. 830

                          [Report No. 105-43]

_______________________________________________________________________

                                 A BILL

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
  Service Act to improve the regulation of food, drugs, devices, and 
              biological products, and for other purposes.

_______________________________________________________________________

                              July 1, 1997

 Reported under authority of the order of the Senate of June 27, 1997, 
                           with an amendment





                                                       Calendar No. 105
105th CONGRESS
  1st Session
                                 S. 830

                          [Report No. 105-43]

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
  Service Act to improve the regulation of food, drugs, devices, and 
              biological products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 5, 1997

 Mr. Jeffords (for himself, Mr. Dodd, Mr. Coats, Ms. Mikulski, and Mr. 
Frist) introduced the following bill; which was read twice and referred 
             to the Committee on Labor and Human Resources

                              July 1, 1997

 Reported under authority of the order of the Senate of June 27, 1997, 
                   by Mr. Jeffords, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
  Service Act to improve the regulation of food, drugs, devices, and 
              biological products, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Food and Drug 
Administration Modernization and Accountability Act of 
1997''.</DELETED>

<DELETED>SEC. 2. TABLE OF CONTENTS.</DELETED>

<DELETED>    The table of contents for this Act is as 
follows:</DELETED>

<DELETED>Sec. 1. Short title.
<DELETED>Sec. 2. Table of contents.
<DELETED>Sec. 3. References.
               <DELETED>TITLE I--IMPROVING PATIENT ACCESS

<DELETED>Sec. 101. Mission of the Food and Drug Administration.
<DELETED>Sec. 102. Expedited access to investigational therapies.
<DELETED>Sec. 103. Expanded humanitarian use of devices.
    <DELETED>TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

<DELETED>Sec. 201. Interagency collaboration.
<DELETED>Sec. 202. Sense of the committee regarding mutual recognition 
                            agreements and global harmonization 
                            efforts.
<DELETED>Sec. 203. Contracts for expert review.
<DELETED>Sec. 204. Accredited-party reviews.
<DELETED>Sec. 205. Device performance standards.
     <DELETED>TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

<DELETED>Sec. 301. Collaborative determinations of device data 
                            requirements.
<DELETED>Sec. 302. Collaborative review process.
      <DELETED>TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

<DELETED>Sec. 401. Policy statements.
<DELETED>Sec. 402. Product classification.
<DELETED>Sec. 403. Use of data relating to premarket approval.
<DELETED>Sec. 404. Consideration of labeling claims for product review.
<DELETED>Sec. 405. Definition of a day for purposes of product review.
<DELETED>Sec. 406. Certainty of review timeframes.
<DELETED>Sec. 407. Limitations on initial classification 
                            determinations.
<DELETED>Sec. 408. Clarification with respect to a general use and 
                            specific use of a device.
<DELETED>Sec. 409. Clarification of the number of required clinical 
                            investigations for approval.
<DELETED>Sec. 410. Prohibited acts.
               <DELETED>TITLE V--IMPROVING ACCOUNTABILITY

<DELETED>Sec. 501. Agency plan for statutory compliance and annual 
                            report.
     <DELETED>TITLE VI--INCREASING RESOURCES BY SETTING PRIORITIES

<DELETED>Sec. 601. Minor modifications.
<DELETED>Sec. 602. Environmental impact review.
<DELETED>Sec. 603. Exemption of certain class devices from premarket 
                            notification requirement.
<DELETED>Sec. 604. Review of class I and class II devices.
<DELETED>Sec. 605. Evaluation of automatic class III designation.
<DELETED>Sec. 606. Secretary's discretion to track devices.
<DELETED>Sec. 607. Secretary's discretion to conduct postmarket 
                            surveillance.
<DELETED>Sec. 608. Reporting.
<DELETED>Sec. 609. Pilot and small-scale manufacture.
<DELETED>Sec. 610. Requirements for radiopharmaceuticals.
<DELETED>Sec. 611. Modernization of regulation of biological products.
<DELETED>Sec. 612. Supplemental new drug applications.
<DELETED>Sec. 613. Health care economic information.
<DELETED>Sec. 614. Expediting study and approval of fast track drugs.
<DELETED>Sec. 615. Manufacturing changes for drugs and biologics.
<DELETED>Sec. 616. Data requirements for drugs and biologics.
<DELETED>Sec. 617. Food contact substances.
<DELETED>Sec. 618. Health claims of food products.
<DELETED>Sec. 619. Pediatric studies marketing exclusivity.
               <DELETED>TITLE VII--FEES RELATING TO DRUGS

<DELETED>Sec. 701. Short title.
<DELETED>Sec. 702. Findings.
<DELETED>Sec. 703. Definitions.
<DELETED>Sec. 704. Authority to assess and use drug fees.
<DELETED>Sec. 705. Annual reports.
<DELETED>Sec. 706. Effective date.
<DELETED>Sec. 707. Termination of effectiveness.
                   <DELETED>TITLE VIII--MISCELLANEOUS

<DELETED>Sec. 801. Registration of foreign establishments.
<DELETED>Sec. 802. Elimination of certain labeling requirements.
<DELETED>Sec. 803. Clarification of seizure authority.
<DELETED>Sec. 804. Intramural research training award program.
<DELETED>Sec. 805. Enforcement authority for special controls.
<DELETED>Sec. 806. Device samples.
<DELETED>Sec. 807. Interstate commerce.

<DELETED>SEC. 3. REFERENCES.</DELETED>

<DELETED>    Except as otherwise expressly provided, wherever in this 
Act an amendment or repeal is expressed in terms of an amendment to, or 
repeal of, a section or other provision, the reference shall be 
considered to be made to a section or other provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).</DELETED>

          <DELETED>TITLE I--IMPROVING PATIENT ACCESS</DELETED>

<DELETED>SEC. 101. MISSION OF THE FOOD AND DRUG 
              ADMINISTRATION.</DELETED>

<DELETED>    Section 903 (21 U.S.C. 393) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsections (b) and (c) as 
        subsections (c) and (d), respectively; and</DELETED>
        <DELETED>    (2) by adding after subsection (a) the 
        following:</DELETED>
<DELETED>    ``(b) Mission.--</DELETED>
        <DELETED>    ``(1) In general.--The Food and Drug 
        Administration shall protect the public health by ensuring 
        that--</DELETED>
                <DELETED>    ``(A) foods are safe, wholesome, and 
                sanitary;</DELETED>
                <DELETED>    ``(B) human and veterinary drugs are safe 
                and effective;</DELETED>
                <DELETED>    ``(C) there is reasonable assurance of 
                safety and effectiveness of devices intended for human 
                use;</DELETED>
                <DELETED>    ``(D) cosmetics are safe; and</DELETED>
                <DELETED>    ``(E) public health and safety are 
                protected from electronic product radiation.</DELETED>
        <DELETED>    ``(2) Special rules.--The Food and Drug 
        Administration shall promptly and efficiently review clinical 
        research and take appropriate action on the marketing of 
        regulated products in a manner that does not unduly impede 
        innovation or product availability. The Food and Drug 
        Administration shall participate with other countries to reduce 
        the burden of regulation, to harmonize regulatory requirements, 
        and to achieve appropriate reciprocal 
        arrangements.''.</DELETED>

<DELETED>SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL 
              THERAPIES.</DELETED>

<DELETED>    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:</DELETED>

<DELETED>``Subchapter D--Unapproved Therapies and Diagnostics</DELETED>

<DELETED>``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 
              DIAGNOSTICS.</DELETED>

<DELETED>    ``(a) In General.--Any person, acting through a medical 
practitioner licensed in accordance with State law, may request from a 
manufacturer or distributor, and any manufacturer or distributor may 
provide to a person after compliance with the provisions of this 
section, an investigational drug (including a biological product) or 
investigational device for the diagnosis, monitoring, or treatment of a 
serious disease or condition, or any other disease or condition 
designated by the Secretary as appropriate for expanded access under 
this section if--</DELETED>
        <DELETED>    ``(1) the licensed medical practitioner determines 
        that the person has no comparable or satisfactory alternative 
        therapy available to diagnose, monitor, or treat the disease or 
        condition involved;</DELETED>
        <DELETED>    ``(2) the licensed medical practioner determines 
        that the risk to the person from the investigational drug or 
        investigational device is not greater than the risk from the 
        disease or condition;</DELETED>
        <DELETED>    ``(3) the Secretary determines that an exemption 
        for the investigational drug or investigational device is in 
        effect under a regulation promulgated pursuant to section 
        505(i) or 520(g) and the sponsor of the drug or device and 
        investigators comply with such regulation;</DELETED>
        <DELETED>    ``(4) the Secretary determines that the 
        manufacturer of the investigational drug or investigational 
        device is actively pursuing marketing approval with due 
        diligence; and</DELETED>
        <DELETED>    ``(5) expanded access will not interfere with 
        adequate enrollment of patients by the investigator in the 
        ongoing clinical investigation authorized under section 505(i) 
        or 520(g).</DELETED>
<DELETED>    ``(b) Protocols.--A manufacturer or distributor may submit 
to the Secretary 1 or more expanded access protocols covering expanded 
access use of a drug or device described in subsection (a). The 
protocols shall be subject to the provisions of section 505(i) or 
520(g) and may include any form of use of the drug or device outside a 
clinical investigation, prior to approval of the drug or device for 
marketing, including protocols for treatment use, emergency use, or 
uncontrolled trials, and single patient protocols.</DELETED>
<DELETED>    ``(c) Notification of Availability.--The Secretary shall 
inform national, State, and local medical associations and societies, 
voluntary health associations, and other appropriate persons about the 
availability of an investigational drug or investigational device under 
expanded access protocols submitted under this section.''.</DELETED>
<DELETED>    (d) Termination.--FDA may at any time terminate expanded 
access under subsection (a) if the requirements under this section are 
no longer met.</DELETED>

<DELETED>SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.</DELETED>

<DELETED>    Section 520(m) (21 U.S.C. 360j(m)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (2), by adding at the end the 
        following flush sentences:</DELETED>
<DELETED>``The request shall be in the form of an application submitted 
to the Secretary. Not later than 60 days after the date of the receipt 
of the application, the Secretary shall issue an order approving or 
denying the application.'';</DELETED>
        <DELETED>    (2) in paragraph (4)(B), by inserting after 
        ``(2)(A)'' the following: ``, unless a physician determines 
        that waiting for such an approval from an institutional review 
        committee will cause harm or death to a patient, and after 
        making a good faith effort, the physician does not receive a 
        timely response from an institutional review committee on the 
        physician's request for approval to use the device.</DELETED>
        <DELETED>    (3) by striking paragraph (5) and inserting the 
        following:</DELETED>
<DELETED>    ``(5) The Secretary may require a person granted an 
exemption under paragraph (2) to demonstrate continued compliance with 
the requirements of this subsection if the Secretary believes such 
demonstration to be necessary to protect the public health or if the 
Secretary has reason to believe that the criteria for the exemption are 
no longer met. Nothing in this section shall be construed to prevent 
the Secretary from using any of the controls authorized by or under 
section 501, 502, 510, 516, 518, 519, or 520, any combination of such 
controls, or any of the special controls established under section 
513(a)(1)(B), in connection with a device for which an exemption has 
been granted under paragraph (2).''.</DELETED>

         <DELETED>TITLE II--INCREASING ACCESS TO EXPERTISE AND 
                          RESOURCES</DELETED>

<DELETED>SEC. 201. INTERAGENCY COLLABORATION.</DELETED>

<DELETED>    Section 903(b) (21 U.S.C. 393(b)) is amended by adding at 
the end the following:</DELETED>
        <DELETED>    ``(3) Interagency collaboration.--The Secretary 
        shall implement programs and policies that will foster 
        collaboration between the Administration, the National 
        Institutes of Health, and other science-based Federal agencies, 
        to enhance the scientific and technical expertise available to 
        the Secretary in the conduct of the Secretary's duties with 
        respect to the development, clinical investigation, evaluation, 
        and postmarket monitoring of emerging medical therapies, 
        including complementary therapies, and advances in nutrition 
        and food science.''.</DELETED>

<DELETED>SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION 
              AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.</DELETED>

<DELETED>    It is the sense of the Committee that--</DELETED>
        <DELETED>    (1) the Secretary of Health and Human Services, in 
        consultation with the Secretary of Commerce, should move toward 
        the acceptance of mutual recognition agreements relating to the 
        regulation of drugs, biological products, devices, foods, food 
        additives, and color additives, and the regulation of good 
        manufacturing practices, reached between the European Union and 
        the United States;</DELETED>
        <DELETED>    (2) the Secretary of Health and Human Services 
        should regularly participate in meetings with representatives 
        of other foreign governments to discuss and reach agreement on 
        methods and approaches to harmonize regulatory requirements; 
        and</DELETED>
        <DELETED>    (3) the Office of International Relations of the 
        Department of Health and Human Services (as established under 
        section 803 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 383)) should have the responsibility of ensuring that 
        the process of harmonizing international regulatory 
        requirements is continuous.</DELETED>

<DELETED>SEC. 203. CONTRACTS FOR EXPERT REVIEW.</DELETED>

<DELETED>    Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at 
the end the following:</DELETED>

<DELETED>``SEC. 906. CONTRACTS FOR EXPERT REVIEW.</DELETED>

<DELETED>    ``(a) In General.--</DELETED>
        <DELETED>    ``(1) Authority.--The Secretary may enter into a 
        contract with any organization or any individual (who is not an 
        employee of the Department) with expertise in a relevant 
        discipline, to review, evaluate, and make recommendations to 
        the Secretary on part or all of any application or submission 
        (including a petition, notification, and any other similar form 
        of request) made under this Act for the approval of an article 
        or made under section 351(a) of the Public Health Service Act 
        (42 U.S.C. 262(a)) with respect to a biological product. Any 
        such contract shall be subject to the requirements of section 
        708 relating to the confidentiality of information.</DELETED>
        <DELETED>    ``(2) Increased efficiency and expertise through 
        contracts.--The Secretary shall use the authority granted in 
        paragraph (1) whenever the Secretary determines that a contract 
        described in paragraph (1) will improve the timeliness or 
        quality of the review of an application or submission described 
        in paragraph (1). Such improvement may include providing the 
        Secretary increased scientific or technical expertise that is 
        necessary to review or evaluate new therapies and 
        technologies.</DELETED>
<DELETED>    ``(b) Review of Expert's Evaluation.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2), the 
        official of the Food and Drug Administration responsible for 
        any matter for which expert review is used pursuant to 
        subsection (a) shall review the recommendations of the 
        organization or individual who conducted the expert review and 
        shall make a final decision regarding the matter within 60 days 
        after receiving the recommendations.</DELETED>
        <DELETED>    ``(2) Limitation.--A final decision under 
        paragraph (1) shall be made within the applicable prescribed 
        time period for review of the matter as set forth in this 
        Act.</DELETED>
        <DELETED>    ``(3) Authority of secretary.--Notwithstanding 
        subsection (a), the Secretary shall retain full authority to 
        make determinations with respect to the approval or disapproval 
        of an article under this Act, or the classification of an 
        article as a device under section 513(f)(1).''.</DELETED>

<DELETED>SEC. 204. ACCREDITED-PARTY REVIEWS.</DELETED>

<DELETED>    Subchapter A of chapter V (21 U.S.C. 351 et seq.) is 
amended by adding at the end the following:</DELETED>

<DELETED>``SEC. 523. ACCREDITED-PARTY PARTICIPATION.</DELETED>

<DELETED>    ``(a) Accreditation.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than 1 year after the 
        date of enactment of this section, the Secretary shall accredit 
        persons, including any entity or individual who is not an 
        employee of United States Government, to review and make 
        recommendations regarding submissions made to the Secretary 
        under section 510(k) except that this paragraph does not apply 
        to submissions for devices that are--</DELETED>
                <DELETED>    ``(A) life-supporting;</DELETED>
                <DELETED>    ``(B) life sustaining; or</DELETED>
                <DELETED>    ``(C) intended for implantation in the 
                human body for a period of over 1 year.</DELETED>
        <DELETED>    ``(2) Special rule.--The Secretary shall have the 
        discretion to accredit persons, including any entity or 
        individual who is not an employee of the United States 
        Government, to review and make recommendations regarding 
        devices described in subparagraphs (A) through (C) of paragraph 
        (1) or devices subject to premarket approval under section 
        515.</DELETED>
<DELETED>    ``(b) Accreditation.--Within 180 days after the date of 
enactment of this section, the Secretary shall adopt methods of 
accreditation that ensure that persons who conduct reviews and make 
recommendations under this section are qualified, properly trained, 
knowledgeable about handling confidential documents and information, 
and free of conflicts of interest. The Secretary shall publish the 
methods of accreditation in the Federal Register on the adoption of the 
methods.</DELETED>
<DELETED>    ``(c) Withdrawal of Accreditation.--The Secretary may 
suspend or withdraw the accreditation of any person accredited under 
this section, after providing notice and an opportunity for an informal 
hearing, if such person acts in a manner that is substantially not in 
compliance with the requirements established by the Secretary, 
including the failure to avoid conflicts of interest, the failure to 
protect confidentiality of information, or the failure to competently 
review premarket submissions for devices.</DELETED>
<DELETED>    ``(d) Selection and Compensation.--A person who intends to 
submit a premarket submission for a device to the Secretary under 
subsection (a) shall have the option to select an accredited person to 
review such submission. Upon the request of a person intending to make 
a premarket submission for a device, the Secretary shall identify for 
the person no less than 2 accredited persons from whom the selection 
may be made. Compensation for an accredited person shall be determined 
by agreement between the accredited person and the person who engages 
the services of the accredited person and shall be paid by the person 
who engages such services.</DELETED>
<DELETED>    ``(e) Review by Secretary.--The Secretary shall require an 
accredited person, upon recommending a classification of a device or 
approval or disapproval of an application for a device, to report to 
the Secretary the reasons of the accredited person for such 
recommendation of classification or approval or disapproval. For 
devices reviewed and initially classified under section 513(f)(1) and 
subject to a report under section 510(k), the Secretary shall have not 
more than 30 days to review the submission. For applications submitted 
under section 515(c)(1), the Secretary shall have not more than 60 days 
to review the application. The Secretary may change the classification 
under section 513(f)(1), or the approval or disapproval of the 
application under section 515(d), that is recommended by the accredited 
person, and in such case shall notify in writing the person making the 
submission of the detailed reasons for the change.</DELETED>
<DELETED>    ``(f) Duration.--The authority provided by this section 
terminates--</DELETED>
        <DELETED>    ``(1) 5 years after the date on which the 
        Secretary notifies Congress that at least 2 persons accredited 
        under subsection (b) are available to review devices in each of 
        at least 70 percent of generic types of devices required for 
        review under subsection (a); or</DELETED>
        <DELETED>    ``(2) 4 years after the date on which the 
        Secretary notifies Congress that at least 35 percent of the 
        devices required for review under subsection (a) that were the 
        subject of final action by the Secretary in the fiscal year 
        preceding the date on which the Secretary notifies the Congress 
        were reviewed by the Secretary under subsection (e),</DELETED>
<DELETED>whichever occurs first.</DELETED>
<DELETED>    ``(g) Report.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than 1 year after the 
        date of enactment of this section, the Secretary shall contract 
        with an independent research organization to prepare and submit 
        to the Secretary a written report examining the use of 
        accredited persons under this section. The Secretary shall 
        submit the report to Congress not later than 6 months prior to 
        the conclusion of the applicable period described in subsection 
        (f).</DELETED>
        <DELETED>    ``(2) Contents.--The report by the independent 
        research organization described in paragraph (1) shall identify 
        the benefits or detriments to public and patient health of 
        using accredited persons to conduct such reviews, and shall 
        summarize all relevant data, including data on the review of 
        accredited persons (including review times, recommendations, 
        and compensation), and data on the review of the Secretary 
        (including review times, changes, and reasons for 
        changes).''.</DELETED>

<DELETED>SEC. 205. DEVICE PERFORMANCE STANDARDS.</DELETED>

<DELETED>    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) 
is amended by adding at the end the following:</DELETED>

             <DELETED>``recognition of a standard</DELETED>

<DELETED>    ``(c)(1)(A) In addition to establishing performance 
standards under this section, the Secretary may, by publication in the 
Federal Register, recognize all or part of a performance standard 
established by a nationally or internationally recognized standard 
development organization for which a person may submit a declaration of 
conformity in order to meet premarket submission requirements or other 
requirements under this Act to which such standards are 
applicable.</DELETED>
<DELETED>    ``(B) If a person elects to use a performance standard 
recognized by the Secretary under subparagraph (A) to meet the 
requirements described in subparagraph (A), the person shall provide a 
declaration of conformity to the Secretary that certifies that the 
device is in conformity with such standard. A person may elect to use 
data, or information, other than data required by a standard recognized 
under subparagraph (A) to fulfill or satisfy any requirement under this 
Act.</DELETED>
<DELETED>    ``(2) The Secretary may withdraw such recognition of a 
performance standard through publication of a notice in the Federal 
Register that the Secretary will no longer recognize the standard, if 
the Secretary determines that the standard is no longer appropriate for 
meeting the requirements under the Act.</DELETED>
<DELETED>    ``(3)(A) Subject to subparagraph (B), the Secretary shall 
accept a declaration of conformity that a device is in conformity with 
a standard recognized under paragraph (1) unless, the Secretary finds--
</DELETED>
        <DELETED>    ``(i) that the data or information submitted to 
        support such declaration does not demonstrate that the device 
        is in conformity with the standard identified in the 
        declaration of conformity; or</DELETED>
        <DELETED>    ``(ii) that the standard identified in the 
        declaration of conformity is not applicable to the particular 
        device under review.</DELETED>
<DELETED>    ``(B) The Secretary may request, at any time, the data or 
information relied on by the person to make a declaration of conformity 
with respect to a standard recognized under paragraph (1).</DELETED>
<DELETED>    ``(C) A person relying on a declaration of conformity with 
respect to a standard recognized under paragraph (1) shall maintain the 
data and information demonstrating conformity of the device to the 
standard for a period of 2 years after the date of the Secretary's 
classification or approval of the device or a time equal to the 
expected design life of a device, whichever is longer.''.</DELETED>
<DELETED>    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended 
by adding at the end the following:</DELETED>
<DELETED>    ``(x) The falsification of a declaration of conformity 
under subsection (c)(3) of section 514 or the failure or refusal to 
provide data or information requested by the Secretary under such 
subsection.''.</DELETED>
<DELETED>    (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is 
amended--</DELETED>
        <DELETED>    (1) by striking ``(e)'' and inserting ``(e)(1)''; 
        and</DELETED>
        <DELETED>    (2) by inserting at the end the 
        following:</DELETED>
<DELETED>    ``(2) If it is, purports to be, or is represented as, a 
device that is declared to be in conformity with any performance 
standard recognized under section 514(c) unless such device is in all 
respects in conformity with such standard.''.</DELETED>

<DELETED>TITLE III--IMPROVING COLLABORATION AND COMMUNICATION</DELETED>

<DELETED>SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA 
              REQUIREMENTS.</DELETED>

<DELETED>    Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by 
adding at the end the following:</DELETED>
<DELETED>    ``(C)(i) The Secretary, upon the written request of any 
person intending to submit an application under section 515, shall meet 
with such person to determine the type of valid scientific evidence 
within the meaning of subparagraphs (A) and (B) that will be necessary 
to demonstrate the effectiveness of a device for the conditions of use 
proposed by such person, to support an approval of an application. 
Within 30 days after such meeting, the Secretary shall specify in 
writing the type of valid scientific evidence that will provide a 
reasonable assurance that a device is effective under the conditions of 
use proposed by such person. Any clinical data, including 1 or more 
well-controlled investigations, specified in writing by the Secretary 
for demonstrating a reasonable assurance of device effectiveness shall 
be specified as a result of a determination by the Secretary that such 
data are necessary to establish device effectiveness and that no other 
less burdensome means of evaluating device effectiveness are available 
which would have a reasonable likelihood of resulting in an 
approval.</DELETED>
<DELETED>    ``(ii) The determination of the Secretary with respect to 
the specification of valid scientific evidence under clause (i) shall 
be binding upon the Secretary, unless--</DELETED>
        <DELETED>    ``(I) such determination by the Secretary would be 
        contrary to the public health; or</DELETED>
        <DELETED>    ``(II) based on new information obtained by the 
        Secretary prior to the approval of an application for an 
        investigational device exemption under section 520(g), the 
Secretary finds that such determination is scientifically 
inappropriate.''.</DELETED>

<DELETED>SEC. 302. COLLABORATIVE REVIEW PROCESS.</DELETED>

<DELETED>    Section 515(d) (21 U.S.C. 360e(d)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)(A), by striking ``paragraph 
        (2) of this subsection'' each place it appears and inserting 
        ``paragraph (4)'';</DELETED>
        <DELETED>    (2) by redesignating paragraphs (2) and (3) as 
        paragraphs (4) and (5), respectively; and</DELETED>
        <DELETED>    (3) by inserting after paragraph (1) the 
        following:</DELETED>
<DELETED>    ``(2)(A) The Secretary shall meet with an applicant not 
later than 100 days after the receipt of an application that has been 
filed as complete under subsection (c) to discuss the review status of 
the application. If the application does not appear in a form that 
would require an approval under this subsection, the Secretary shall in 
writing, and prior to the meeting, provide to the applicant a 
description of any deficiencies in the application identified by the 
Secretary and identify the information (other than information the 
Secretary needs to making a finding under paragraph (4)(C)) that is 
required to bring the application into a form that would require an 
approval. The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under this 
paragraph.</DELETED>
<DELETED>    ``(B) The Secretary shall notify the applicant immediately 
of any deficiency identified in the application that was not described 
as a deficiency in the written description provided by the Secretary 
under subparagraph (A).''.</DELETED>

 <DELETED>TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES</DELETED>

<DELETED>SEC. 401. POLICY STATEMENTS.</DELETED>

<DELETED>    Section 701(a) (21 U.S.C. 371(a)) is amended--</DELETED>
        <DELETED>    (1) by striking ``(a) The'' and inserting ``(a)(1) 
        The''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>    ``(2) Not later than February 27, 1999, the Secretary, 
after evaluating the effectiveness of the Good Guidance Practices 
document published in the Federal Register at 62 Fed. Reg. 8961, shall 
promulgate as a regulation in the Federal Register the policies and 
procedures of the Food and Drug Administration for the development, 
issuance, and use of guidance documents.''.</DELETED>

<DELETED>SEC. 402. PRODUCT CLASSIFICATION.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.) is amended by adding 
at the end the following:</DELETED>

   <DELETED>``Subchapter D--Review of Applications and Environmental 
                        Impact Reviews</DELETED>

<DELETED>``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION OR 
              SUBMISSION.</DELETED>

<DELETED>    ``(a) Classification of a Product.--</DELETED>
        <DELETED>    ``(1) Request.--A person who submits an 
        application or submission (including a petition, notification, 
        and any other similar form of request) under this Act, may 
        submit a request to the Secretary respecting the classification 
        of an article (including an article that is a combination 
        product subject to section 503(g)) as a drug, biological 
        product, or device, or respecting the component of the Food and 
        Drug Administration that will regulate the article. In 
        submitting the request, the person shall recommend a 
        classification for the article, or the component that should 
        regulate the article, as appropriate.</DELETED>
        <DELETED>    ``(2) Statement.--Not later than 60 days after the 
        receipt of the request described in paragraph (1), the 
        Secretary shall determine the classification of the article or 
        the component of the Food and Drug Administration that will 
        regulate the article and shall provide to the person a written 
        statement that identifies the classification of the article or 
        the component of the Food and Drug Administration that will 
        regulate the article and the reasons for such determination. 
        The Secretary may not modify such statement except with the 
        written consent of the person or for public health 
        reasons.</DELETED>
        <DELETED>    ``(3) Inaction of secretary.--If the Secretary 
        does not provide the statement within the 60-day period 
        described in paragraph (2), the recommendation made by the 
        person under paragraph (1) shall be considered to be a final 
        determination by the Secretary of the classification of the 
        article or the component of the Food and Drug Administration 
        that will regulate the article and may not be modified by the 
        Secretary except with the written consent of the person or for 
        public health reasons.''.</DELETED>

<DELETED>SEC. 403. USE OF DATA RELATING TO PREMARKET 
              APPROVAL.</DELETED>

<DELETED>    Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to 
read as follows:</DELETED>
<DELETED>    ``(4)(A) Any information contained in an application for 
premarket approval filed with the Secretary pursuant to section 515(c) 
(including clinical and preclinical tests or studies that demonstrate 
the safety and effectiveness of a device, but excluding descriptions of 
methods of manufacture and product composition) shall be available, 
6 years after the application has been approved by the Secretary, for 
use by the Secretary in--</DELETED>
        <DELETED>    ``(i) approving devices;</DELETED>
        <DELETED>    ``(ii) determining whether a product development 
        protocol has been completed, under section 515;</DELETED>
        <DELETED>    ``(iii) establishing a performance standard or 
        special control under section 514; and</DELETED>
        <DELETED>    ``(iv) classifying or reclassifying devices under 
        section 513 and subsection (l)(2).</DELETED>
<DELETED>    ``(B) The publicly available detailed summaries of 
information respecting the safety and effectiveness of devices required 
by paragraph (1)(A) shall be available for use by the Secretary as the 
evidentiary basis for the regulatory action described in subparagraph 
(A).''.</DELETED>

<DELETED>SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT 
              REVIEW.</DELETED>

<DELETED>    (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 
360e(d)(1)(A)) is amended by adding at the end the following flush 
sentences:</DELETED>
<DELETED>``In making the determination whether to approve or deny an 
application, the Secretary shall rely on the conditions of use proposed 
in the labeling of a device as the basis for determining whether or not 
there is a reasonable assurance of safety and effectiveness. If, based 
on a fair evaluation of all material facts, the proposed labeling is 
neither false nor misleading in any particular, the Secretary, in 
making the determination, shall not consider conditions of use not 
included in the proposed labeling.''.</DELETED>
<DELETED>    (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 
360c(i)(1)) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(C) Whenever the Secretary requests information to 
demonstrate that the devices with differing technological 
characteristics are substantially equivalent, the Secretary shall only 
request information that is necessary to make a substantial equivalence 
determination. In making such a request, the Secretary shall consider 
the least burdensome means of demonstrating substantial equivalence and 
shall request information accordingly.</DELETED>
<DELETED>    ``(D) Any determinations of substantial equivalence by the 
Secretary shall be based upon the intended uses proposed in labeling 
submitted in a report under section 510(k).''.</DELETED>

<DELETED>SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT 
              REVIEW.</DELETED>

<DELETED>    Section 201 (21 U.S.C. 321) is amended by adding at the 
end the following:</DELETED>
<DELETED>    ``(ii) In any provision relating to a review of any 
application or submission (including a petition, notification, and any 
other similar form of request), made under this Act with respect to an 
article that is a new drug, device, biological product, new animal 
drug, an animal feed bearing or containing a new animal drug, color 
additive, or food additive, that is submitted to the Secretary to 
obtain marketing approval, to obtain classification of a device under 
section 513(f)(1), or to establish or clarify the regulatory status of 
the article, the term `day' means a calendar day in which the Secretary 
has responsibility to review such an application or submission 
(excluding any calendar day between the date of receipt, by the person 
submitting the application or submission, of a written communication 
from the Secretary setting forth the action of the Secretary on the 
application or submission and the date of receipt by the Secretary of 
the written response of the person to the action).''.</DELETED>

<DELETED>SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES.</DELETED>

<DELETED>    (a) Clarification on the 90-Day Timeframe for Premarket 
Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by 
adding at the end the following flush sentence:</DELETED>
<DELETED>``The Secretary shall review the notification required by this 
subsection and make a determination under section 513(f)(1) not later 
than 90 days after receiving the notification.''.</DELETED>
<DELETED>    (b) Certainty of 180-Day Review Time Frame.--Section 
515(d) (21 U.S.C. 360e(d)), as amended by section 302, is amended by 
inserting after paragraph (2) the following:</DELETED>
<DELETED>    ``(3) The time for the review of an application by the 
Secretary under this subsection shall take not more than 180 days and 
such time may not be extended if the application is 
amended.''.</DELETED>

<DELETED>SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION 
              DETERMINATIONS.</DELETED>

<DELETED>    Section 510 (21 U.S.C. 360) is amended by adding at the 
end the following:</DELETED>
<DELETED>    ``(m)(1) The Secretary may not withhold a determination of 
the initial classification of a device under section 513(f)(1) because 
of a failure to comply with any provision of this Act that is unrelated 
to a substantial equivalence decision, including a failure to comply 
with the requirements relating to good manufacturing practices under 
section 520(f).</DELETED>
<DELETED>    ``(2) Nothing in this provision shall be construed to 
prevent the Secretary from using any of the controls authorized by or 
under section 501, 502, 510, 516, 518, 519, or 520, or any combination 
of such controls, or any of the special controls established under 
section 513(a)(1)(B) to regulate a marketed device.''.</DELETED>

<DELETED>SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND 
              SPECIFIC USE OF A DEVICE.</DELETED>

<DELETED>    Not later than 270 days after the date of enactment of 
this section, the Secretary shall promulgate a final regulation 
specifying the general principles that the Secretary will consider in 
determining when a specific intended use of a device is not reasonably 
included within a general use of such device for purposes of a 
determination of substantial equivalence under section 513(f)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(f)(1)) .</DELETED>

<DELETED>SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
              INVESTIGATIONS FOR APPROVAL.</DELETED>

<DELETED>    (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 
360c(a)(3)(A)) is amended by striking ``clinical investigations'' and 
inserting ``one or more clinical investigations''.</DELETED>
<DELETED>    (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is 
amended by adding at the end the following: ``If the Secretary 
determines that only one investigation is required, then the Secretary 
may require appropriate supporting scientific evidence obtained prior 
to or after such investigation. The Secretary shall establish a 
mechanism to ensure the fair and consistent application of this 
provision to new drugs''.</DELETED>

<DELETED>SEC. 410. PROHIBITED ACTS.</DELETED>

<DELETED>    Section 301(l) (21 U.S.C. 331(l) is repealed.</DELETED>

          <DELETED>TITLE V--IMPROVING ACCOUNTABILITY</DELETED>

<DELETED>SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL 
              REPORT.</DELETED>

<DELETED>    Section 903(b) (21 U.S.C. 393(b)), as amended by section 
201, is further amended by adding at the end the following:</DELETED>
        <DELETED>    ``(4) Agency plan for statutory compliance.--
        </DELETED>
                <DELETED>    ``(A) In general.--Not later than 180 days 
                after the date of enactment of this paragraph, the 
                Secretary, after consultation with relevant experts, 
                health care professionals, and representatives of 
                patient and consumer advocacy groups, and the regulated 
                industry, shall develop and publish in the Federal 
                Register a plan bringing the Secretary into compliance 
                with each of the obligations of the Secretary under 
                this Act and other relevant statutes. The Secretary 
                shall biannually review the plan and shall revise the 
                plan as necessary, in consultation with such 
                persons.</DELETED>
                <DELETED>    ``(B) Objectives of agency plan.--The plan 
                required by subparagraph (A) shall establish objectives 
                for and mechanisms to be used by the Secretary, acting 
                through the Commissioner, including objectives and 
                mechanisms that--</DELETED>
                        <DELETED>    ``(i) minimize deaths of, and harm 
                        to, persons who use or may use an article 
                        regulated under this Act;</DELETED>
                        <DELETED>    ``(ii) maximize the clarity of, 
                        and the availability of information about, the 
                        process for review of applications and 
                        submissions (including petitions, 
                        notifications, and any other similar forms of 
                        request) made under this Act, including 
                        information for potential consumers and 
                        patients concerning new products;</DELETED>
                        <DELETED>    ``(iii) implement all inspection 
                        and postmarket monitoring provisions of this 
                        Act by July 1, 1999;</DELETED>
                        <DELETED>    ``(iv) ensure access to the 
                        scientific and technical expertise necessary to 
                        ensure compliance by the Secretary with the 
                        statutory obligations described in subparagraph 
                        (A);</DELETED>
                        <DELETED>    ``(v) establish a schedule to 
                        bring the Administration into full compliance 
                        by July 1, 1999, with the time periods 
                        specified in this Act for the review of all 
                        applications and submissions described in 
                        clause (ii) and submitted after the date of 
                        enactment of this paragraph; and</DELETED>
                        <DELETED>    ``(vi) reduce backlogs in the 
                        review of all applications and submissions 
                        described in clause (ii) for any article with 
                        the objective of eliminating all backlogs in 
                        the review of the applications and submissions 
                        by January 1, 2000.</DELETED>
        <DELETED>    ``(5) Annual report.--</DELETED>
                <DELETED>    ``(A) Contents.--The Secretary shall 
                prepare and publish in the Federal Register and solicit 
                public comment on an annual report that--</DELETED>
                        <DELETED>    ``(i) provides detailed 
                        statistical information on the performance of 
                        the Secretary under the plan described in 
                        paragraph (4);</DELETED>
                        <DELETED>    ``(ii) compares such performance 
                        of the Secretary with the objectives of the 
                        plan and with the statutory obligations of the 
                        Secretary;</DELETED>
                        <DELETED>    ``(iii) analyzes any failure of 
                        the Secretary to achieve any objective of the 
                        plan or to meet any statutory 
                        obligation;</DELETED>
                        <DELETED>    ``(iv) identifies any regulatory 
                        policy that has a significant impact on 
                        compliance with any objective of the plan or 
                        any statutory obligation; and</DELETED>
                        <DELETED>    ``(v) sets forth any proposed 
                        revision to any such regulatory policy, or 
                        objective of the plan that has not been 
                        met.</DELETED>
                <DELETED>    ``(B) Statistical information.--The 
                statistical information described in subparagraph 
                (A)(i) shall include a full statistical presentation 
                relating to all applications and submissions (including 
                petitions, notifications, and any other similar forms 
                of request) made under this Act and approved or subject 
                to final action by the Secretary during the year 
                covered by the report. In preparing the statistical 
                presentation, the Secretary shall take into account the 
                date of--</DELETED>
                        <DELETED>    ``(i) the submission of any 
                        investigational application;</DELETED>
                        <DELETED>    ``(ii) the application of any 
                        clinical hold;</DELETED>
                        <DELETED>    ``(iii) the submission of any 
                        application or submission (including a 
                        petition, notification, and any other similar 
                        form of request) made under this Act for 
                        approval or clearance;</DELETED>
                        <DELETED>    ``(iv) the acceptance for filing 
                        of any application or submission described in 
                        clause (iii) for approval or 
                        clearance;</DELETED>
                        <DELETED>    ``(v) the occurrence of any 
                        unapprovable action;</DELETED>
                        <DELETED>    ``(vi) the occurrence of any 
                        approvable action; and</DELETED>
                        <DELETED>    ``(vii) the approval or clearance 
                        of any application or submission described in 
                        clause (iii).''.</DELETED>

<DELETED>TITLE VI--INCREASING RESOURCES BY SETTING PRIORITIES</DELETED>

<DELETED>SEC. 601. MINOR MODIFICATIONS.</DELETED>

<DELETED>    (a) Procedures and Conditions.--Section 520(g) (21 U.S.C. 
360j(g)) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(6)(A) The Secretary shall, not later than 120 days 
after the date of enactment of this paragraph, by regulation modify 
parts 812 and 813 of title 21, Code of Federal Regulations to update 
the procedures and conditions under which a device intended for human 
use may, upon application by the sponsor of the device, be granted an 
exemption from certain requirements under this Act.</DELETED>
<DELETED>    ``(B) The regulation shall permit developmental changes in 
devices (including manufacturing changes) in response to information 
collected during an investigation without requiring an additional 
approval of an application for an investigational device exemption or 
the approval of a supplement to such application, if the sponsor of the 
investigation determines, prior to making any changes, that the 
changes--</DELETED>
        <DELETED>    ``(i) do not affect the scientific soundness of an 
        investigational plan submitted under paragraph (3)(A) or the 
        rights, safety, or welfare of the human subjects involved in 
        the investigation; and</DELETED>
        <DELETED>    ``(ii) do not constitute a significant change in 
        design, or a significant change in basic principles of 
        operation, of the device.''.</DELETED>
<DELETED>    (b) Action on Application.--Section 515(d)(1)(B) (21 
U.S.C. 360e(d)(1)(B)) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(iii) The Secretary shall accept and review data and any 
other information from investigations conducted under the authority of 
regulations required by section 520(g) to make a determination of 
whether there is a reasonable assurance of safety and effectiveness of 
a device subject to a pending application under this section if--
</DELETED>
        <DELETED>    ``(I) the data or information is derived from 
        investigations of an earlier version of the device, the device 
        has been modified during or after the investigations (but prior 
        to submission of an application under section 515(c)) and such 
        a modification of the device does not constitute a significant 
        change in the design or in the basic principles of operation of 
        the device that would invalidate the data or information; 
        or</DELETED>
        <DELETED>    ``(II) the data or information relates to a device 
        approved under this section, is available for use under this 
Act, and is relevant to the design and intended use of the device 
subject to the pending application.''.</DELETED>
<DELETED>    (c) Action on Supplements.--Section 515(d) (21 U.S.C. 
360e(d)), as amended by section 302, is further amended by adding at 
the end the following:</DELETED>
<DELETED>    ``(6)(A) A supplemental application shall be required for 
any change to a device subject to an approved application under this 
subsection that affects safety or effectiveness, unless such change is 
a modification in a manufacturing procedure or method of manufacturing 
and the holder of an approved application submits a written notice to 
the Secretary that describes the change and informs the Secretary that 
the change has been made under the requirements of section 
520(f).</DELETED>
<DELETED>    ``(B)(i) Subject to clause (ii), in reviewing a supplement 
to an approved application for an incremental change to the design of a 
device that affects safety or effectiveness, the Secretary shall 
approve such supplement if--</DELETED>
        <DELETED>    ``(I) nonclinical data demonstrate that a design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and</DELETED>
        <DELETED>    ``(II) clinical data from the approved application 
        and any supplement to the approved application provide a 
        reasonable assurance of safety and effectiveness.</DELETED>
<DELETED>    ``(ii) The Secretary may require, when necessary, 
additional clinical data to evaluate the design modification to provide 
a reasonable assurance of safety and effectiveness.''.</DELETED>

<DELETED>SEC. 602. ENVIRONMENTAL IMPACT REVIEW.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
402, is further amended by adding at the end the following:</DELETED>

<DELETED>``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.</DELETED>

<DELETED>    ``Notwithstanding any other provision of law, no action by 
the Secretary pursuant to this Act shall be subject to an environmental 
assessment, an environmental impact statement, or other environmental 
consideration unless the Secretary demonstrates, in writing--</DELETED>
        <DELETED>    ``(1) that there is a reasonable probability that 
        the environmental impact of the action is sufficiently 
        substantial and within the factors that the Secretary is 
        authorized to consider under this Act; and</DELETED>
        <DELETED>    ``(2) that consideration of the environmental 
        impact will directly affect the decision on the 
        action.''.</DELETED>

<DELETED>SEC. 603. EXEMPTION OF CERTAIN CLASS DEVICES FROM PREMARKET 
              NOTIFICATION REQUIREMENT.</DELETED>

<DELETED>    Section 510 (21 U.S.C. 360) is amended inserting after 
subsection (k) the following:</DELETED>
<DELETED>    ``(l)(1) Not later than 30 days after the date of 
enactment of this subsection, the Secretary shall publish in the 
Federal Register a list of each type of class II device that does not 
require a notification under subsection (k) to provide reasonable 
assurance of safety and effectiveness. Each type of class II device 
identified by the Secretary not to require the notification shall be 
exempt from the requirement to provide notification under subsection 
(k) as of the date of the publication of the list in the Federal 
Register.</DELETED>
<DELETED>    ``(2) Beginning on the date that is 1 day after the date 
of the publication of a list under this subsection, any person may 
petition the Secretary to exempt a type of class II device from the 
notification requirement of subsection (k). The Secretary shall publish 
notice of the petition in the Federal Register and provide a 30-day 
period for public comment. The Secretary shall respond to the petition 
within 120 days after the receipt of the petition and determine whether 
or not to grant the petition in whole or in part.''.</DELETED>

<DELETED>SEC. 604. REVIEW OF CLASS I AND CLASS II DEVICES.</DELETED>

<DELETED>    (a) Exemption From Premarket Notification.--Section 510(k) 
(21 U.S.C. 360(k)) is amended by striking ``intended for human use'' 
and inserting ``intended for human use (except a device that is 
classified into class I under section 513 or 520 unless such device is 
intended for a use which is of substantial importance in preventing 
impairment of human health, or presents a potential unreasonable risk 
of illness or injury, or a device that is classified into class II 
under section 513 or 520 and is exempt from the requirements of this 
subsection under subsection (l))''.</DELETED>

<DELETED>SEC. 605. EVALUATION OF AUTOMATIC CLASS III 
              DESIGNATION.</DELETED>

<DELETED>    Section 513(f) (21 U.S.C. 360c(f)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1) in the last sentence, by 
        striking ``paragraph (2)'' and inserting ``paragraph (2) or 
        (3)'';</DELETED>
        <DELETED>    (2) by redesignating paragraphs (2) and (3) as 
        paragraphs (3) and (4), respectively; and</DELETED>
        <DELETED>    (3) by inserting after paragraph (1) the 
        following:</DELETED>
<DELETED>    ``(2)(A) Any person who submits a report under section 
510(k) for a type of device that has not been previously classified 
under this Act, and which is classified into class III under paragraph 
(1), may request, within 30 days after receiving written notice of such 
a classification, the Secretary to classify the device into class I or 
II under the criteria set forth in subsection (a)(1). The person may, 
in the request, recommend to the Secretary the classification for the 
device. The request shall describe the device and provide detailed 
information and reasons for the recommended classification.</DELETED>
<DELETED>    ``(B)(i) Not later than 60 days after the date of the 
request under subparagraph (A) for classification of a device under the 
criteria set forth in subparagraphs (A) through (C) of section 
513(a)(1), the Secretary shall by written order classify the device. 
Such classification shall be the initial classification of the device 
for purposes of paragraph (1) and any device classified under this 
paragraph into class I or II shall be a predicate device for 
determining substantial equivalence under paragraph (1).</DELETED>
<DELETED>    ``(ii) A device that remains in class III under this 
subparagraph shall be deemed adulterated within the meaning of section 
501(f)(1)(B) until approved under section 515 or exempted from such 
approval under section 520(g).</DELETED>
<DELETED>    ``(C) Following the issuance of an order classifying a 
device under this paragraph, the Secretary shall, within 30 days after 
the date of the issuance of the order, publish a notice in the Federal 
Register announcing such classification.''.</DELETED>

<DELETED>SEC. 606. SECRETARY'S DISCRETION TO TRACK DEVICES.</DELETED>

<DELETED>    (a) Release of Information.--Section 519(e) (21 U.S.C. 
360i(e)) is amended by adding at the end the following flush 
sentence:</DELETED>
<DELETED>``Any patient receiving a device subject to tracking under 
this section may refuse to release, or refuse permission to release, 
the patient's name, address, social security number, or other 
identifying information for the purpose of tracking.''.</DELETED>
<DELETED>    (b) Publication of Certain Devices.--Not later than 180 
days after the date of enactment of this Act, the Secretary shall 
develop and publish in the Federal Register a list that identifies each 
type of device subject to tracking under section 519(e)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)). Each device 
not identified by the Secretary under this subsection shall be deemed 
to be exempt from the mandatory tracking requirement under section 519 
of such Act.</DELETED>

<DELETED>SEC. 607. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET 
              SURVEILLANCE.</DELETED>

<DELETED>    (a) In General.--Section 522 (21 U.S.C. 360l) is amended 
by striking ``Sec. 522.'' and all that follows through ``(2) 
Discretionary surveillance.--The'' and inserting the 
following:</DELETED>
<DELETED>    ``Sec. 522. (a) Discretionary Surveillance.--
The''.</DELETED>
<DELETED>    (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 
360l(b)) is amended to read as follows:</DELETED>
<DELETED>    ``(b) Surveillance Approval.--</DELETED>
        <DELETED>    ``(1) In general.--Each manufacturer required to 
        conduct a surveillance of a device under subsection (a) shall, 
        not later than 30 days after receiving notice from the 
        Secretary that the manufacturer is required under this section 
        to conduct the surveillance, submit for the approval of the 
        Secretary, a plan for the required surveillance.</DELETED>
        <DELETED>    ``(2) Determination.--Not later than 60 days after 
        the receipt of the plan, the Secretary shall determine if a 
        person proposed to be used to conduct the surveillance has 
        sufficient qualifications and experience to conduct the 
        surveillance and if the plan will result in the collection of 
        useful data that can reveal unforeseen adverse events or other 
        information necessary to protect the public health and to 
        provide safety and effectiveness information for the 
        device.</DELETED>
        <DELETED>    ``(3) Limitation on plan approval.--The Secretary 
        may not approve the plan until the plan has been reviewed by a 
        qualified scientific and technical review committee established 
        by the Secretary.''.</DELETED>
<DELETED>    (c) Duration of Surveillance.--Section 522 (21 U.S.C. 
360l), as amended by subsection (b), is further amended by adding at 
the end the following:</DELETED>
<DELETED>    ``(c) Duration of Surveillance.--</DELETED>
        <DELETED>    ``(1) In general.--Each manufacturer required to 
        conduct a surveillance of a device under subsection (a) shall 
        be required to conduct such surveillance for not longer than 24 
        months.</DELETED>
        <DELETED>    ``(2) Extension of the period of surveillance.--If 
        the Secretary determines that additional surveillance is needed 
        to identify the incidence of adverse events documented during 
        the initial period of surveillance that were not foreseen at 
        the time of approval or classification of the device, the 
        Secretary may extend the period of surveillance for such time 
        as may be necessary after providing the person required to 
        conduct such surveillance an opportunity for an informal 
        hearing to determine whether or not additional surveillance is 
        appropriate and to determine the appropriate period, if any, 
        for such surveillance.''.</DELETED>

<DELETED>SEC. 608. REPORTING.</DELETED>

<DELETED>    Section 519 (21 U.S.C. 360i) is amended--</DELETED>
        <DELETED>    (1) by striking ``, importer, or distributor'' 
        each place it appears and inserting ``or importer'';</DELETED>
        <DELETED>    (2) in subsection (a)--</DELETED>
                <DELETED>    (A) in paragraph (7), by striking the 
                semicolon at the end and inserting ``; and'';</DELETED>
                <DELETED>    (B) in paragraph (8), by striking ``; 
                and'' and inserting a period; and</DELETED>
                <DELETED>    (C) by striking paragraph (9); 
                and</DELETED>
        <DELETED>    (3) by striking subsection (d).</DELETED>

<DELETED>SEC. 609. PILOT AND SMALL-SCALE MANUFACTURE.</DELETED>

<DELETED>    Section 505(c) (21 U.S.C. 355(c)) is amended by adding at 
the end the following:</DELETED>
<DELETED>    ``(4) An application shall be approved based on 
information obtained from products manufactured in a pilot or other 
small facility so long as the commercial manufacturing process is 
validated prior to product distribution pursuant to a protocol 
submitted with the application, unless the Secretary specifies in 
writing the reasons why information from a full scale production 
facility is necessary to ensure the safety or effectiveness of the 
drug.''.</DELETED>

<DELETED>SEC. 610. REQUIREMENTS FOR RADIOPHARMACEUTICALS.</DELETED>

<DELETED>    (a) Requirements.--</DELETED>
        <DELETED>    (1) Regulations.--Not later than 180 days after 
        the date of enactment of this Act, the Secretary of Health and 
        Human Services, after consultation with patient advocacy 
        groups, associations, physicians licensed to use 
        radiopharmaceuticals, and the regulated industry, shall 
        establish proposed regulations governing the approval of 
        radiopharmaceutical articles designed for diagnosis and 
        monitoring of diseases and conditions. The regulations shall 
        provide that the safety and effectiveness of a 
        radiopharmaceutical shall be evaluated taking into account the 
        appropriate use of radiopharmaceutical in the practice of 
        medicine, the pharmacological and toxicological activity of the 
        radiopharmaceutical, and the estimated absorbed radiation dose 
        of the radiopharmaceutical. Not later than 1 year after the 
        date of enactment of this Act, the Secretary shall promulgate 
        the final regulations governing the approval of the 
        radiopharmaceutical.</DELETED>
        <DELETED>    (2) Special Rule.--In the case of a 
        radiopharmaceutical intended to be used for diagnostic 
        purposes, the indications for which such radiopharmaceutical is 
        approved for marketing may refer to manifestations of disease 
        (such as biochemical, physiological, anatomic, or pathological 
        processes) common to or present in 1 or more disease states, or 
        may refer to a diagnostic procedure used in the diagnosis of 1 
        or more diseases or conditions.</DELETED>
<DELETED>    (b) Definition.--In this section, the term 
``radiopharmaceutical'' means--</DELETED>
        <DELETED>    (1) an article--</DELETED>
                <DELETED>    (A) that is intended for use in vivo in 
                the diagnosis, cure, mitigation, treatment, or 
                prevention of a disease or a manifestation of disease 
                in man; and</DELETED>
                <DELETED>    (B) that exerts its primary effect through 
                its pharmacokinetics and the spontaneous disintegration 
                of unstable nuclei with the emission of ionizing 
                radiation; or</DELETED>
        <DELETED>    (2) a reagent kit or nuclide generator that is 
        intended to be used in the preparation of any such 
        article.</DELETED>

<DELETED>SEC. 611. MODERNIZATION OF REGULATION OF BIOLOGICAL 
              PRODUCTS.</DELETED>

<DELETED>    (a) Licenses.--</DELETED>
        <DELETED>    (1) In general.--Section 351(a) of the Public 
        Health Service (42 U.S.C. 262(a)) is amended to read as 
        follows:</DELETED>

          <DELETED>regulation of biological products</DELETED>

<DELETED>    ``Sec. 351. (a)(1) Except as provided in paragraph (4), no 
person shall introduce or deliver for introduction into interstate 
commerce any biological product unless--</DELETED>
        <DELETED>    ``(A) a biologics license is in effect for the 
        biological product; and</DELETED>
        <DELETED>    ``(B) each package of the biological product is 
        plainly marked with the proper name of the biological product 
        contained in the package, the name, address, and applicable 
        license number of the manufacturer of the biological product, 
        and the expiration date of the biological product.</DELETED>
<DELETED>    ``(2)(A) The Secretary shall establish, by regulation, 
requirements for the approval, suspension, and revocation of biologics 
licenses.</DELETED>
<DELETED>    ``(B) A biologics license application shall be approved 
based upon a demonstration that--</DELETED>
        <DELETED>    ``(i) the biological product that is the subject 
        of the application is safe, pure, and potent; and</DELETED>
        <DELETED>    ``(ii) the facility in which the biological 
        product is manufactured, processed, packed, or held meets 
        standards designed to assure that the biological product 
        continues to be safe, pure, and potent.</DELETED>
<DELETED>    ``(3) A demonstration under paragraph (2)(B)(i) may be 
made on the basis of 1 or more clinical trials, or other requirements 
established by the Secretary under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355).</DELETED>
<DELETED>    ``(4) The Secretary shall prescribe requirements under 
which a biological product undergoing investigation shall be exempt 
from the requirements of paragraph (1).''.</DELETED>
        <DELETED>    (2) Elimination of existing license requirement.--
        Section 351(d) of the Public Health Service Act (42 U.S.C. 
        262(d)) is amended--</DELETED>
        <DELETED>    (A) by striking ``(d)(1)'' and all that follows 
        through ``of this section.'';</DELETED>
        <DELETED>    (B) in paragraph (2),</DELETED>
                <DELETED>    (i) by striking ``(2)(A) Upon'' and 
                inserting ``(d)(1) Upon''; and</DELETED>
                <DELETED>    (ii) by redesignating subparagraph (B) as 
                paragraph (2); and</DELETED>
        <DELETED>    (C) in paragraph (2), (as so redesignated by 
        subparagraph (B)(ii)), by striking ``subparagraph (A)'' and 
        inserting ``paragraph (1)''.</DELETED>
<DELETED>    (b) Labeling.--Section 351(b) of the Public Health Service 
Act (42 U.S.C. 262(b)) is amended to read as follows:</DELETED>
<DELETED>    ``(b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark on the 
package or container so as to falsify the label or mark.''.</DELETED>
<DELETED>    (c) Inspection.--Section 351(c) of the Public Health 
Service Act (42 U.S.C. 262(c)) is amended by striking ``virus, serum,'' 
and all that follows and inserting ``biological product.''.</DELETED>
<DELETED>    (d) Definition; Application.--Part F of title III of the 
Public Health Service Act (42 U.S.C. 262 et seq.) is amended by adding 
at the end the following:</DELETED>
<DELETED>    ``(i) For purposes of this section, the term ``biological 
product'' means a virus, therapeutic serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic product, analogous 
product, or arsphenamine or its derivatives (or any other trivalent 
organic arsenic compound) applicable to the prevention, treatment, or 
cure of diseases or conditions of human beings.''.</DELETED>
<DELETED>    (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 
353(g)(4)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (A), by striking ``section 
        351(a)'' and inserting ``section 351(i)''; and</DELETED>
        <DELETED>    (2) in subparagraph (B)(iii), by striking 
        ``product or establishment license under subsection (a) or 
        (d)'' and inserting ``biologics license application under 
        subsection (a)''.</DELETED>
<DELETED>    (f) Special rule.--The Secretary of Health and Human 
Services shall take measures to minimize differences in the review and 
approval of products required to have biological license applications 
under section 351 of the Public Health Service Act (42 U.S.C. 262) and 
products required to have full new drug applications under section 
505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355).</DELETED>

<DELETED>SEC. 612. SUPPLEMENTAL NEW DRUG APPLICATIONS.</DELETED>

<DELETED>    Section 505(d) (21 U.S.C. 355(d)) is amended by adding at 
the end the following:</DELETED>
<DELETED>    ``(7) The Secretary may approve a supplement to an 
approved application for an additional use for the drug on the basis of 
literature reports, reliable clinical experience, or persuasive 
scientific evidence, the totality of which is sufficient to demonstrate 
the effectiveness of the drug for the use involved.''.</DELETED>

<DELETED>SEC. 613. HEALTH CARE ECONOMIC INFORMATION.</DELETED>

<DELETED>    Section 502 (21 U.S.C. 352) is amended by adding at the 
end the following:</DELETED>
<DELETED>    ``(u) In the case of a health care economic statement that 
is included in labeling or advertising provided to a formulary 
committee, managed care organization, or similar entity with 
responsibility for drug selection decisions (other than the label or 
approved physician package insert relating to an indication approved 
under section 505 or 351 of the Public Health Service Act) if the 
health care economic statement is not competent and reliable. Any such 
statement shall be subject solely to this paragraph. In this paragraph, 
the term `health care economic statement' means any statement that 
identifies, measures, or compares the costs (direct, indirect, and 
intangible) and health care consequences of a drug to another drug or 
to another health care intervention for the same indication, or to no 
intervention, where the primary endpoint is an economic 
outcome.''.</DELETED>

<DELETED>SEC. 614. EXPEDITING STUDY AND APPROVAL OF FAST TRACK 
              DRUGS.</DELETED>

<DELETED>    (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as 
amended by section 102, is further amended by adding at the end the 
following:</DELETED>

          <DELETED>``Subchapter E--Fast Track Drugs</DELETED>

<DELETED>``SEC. 561. FAST TRACK DRUGS.</DELETED>

<DELETED>    ``(a) Designation of Drug as a Fast Track Drug.--
</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall facilitate 
        development, and expedite approval, of new drugs and biological 
        products that are intended for the treatment of serious or 
        life-threatening conditions and that demonstrate the potential 
        to address unmet medical needs for such conditions. For 
        purposes of this Act, such products shall be known as `fast 
        track drugs'.</DELETED>
        <DELETED>    ``(2) Request for designation.--The sponsor of a 
        drug may request the Secretary to designate the drug as a fast 
        track drug. A request for designation may be made concurrently 
        with, or at any time after, submission of an application for 
        the investigation of the drug under section 505(i).</DELETED>
        <DELETED>    ``(3) Designation.--Within 30 calendar days after 
        the receipt of a request under paragraph (2), the Secretary 
        shall determine whether the drug that is the subject of the 
        request is being, or will be, investigated for treatment of a 
        condition described in paragraph (1). If the Secretary finds 
        that the drug is intended for such treatment, the Secretary 
        shall designate the drug as a fast track drug and shall take 
        such actions as are appropriate to expedite the development and 
        review of the drug.</DELETED>
<DELETED>    ``(b) Approval of Application for a Fast Track Drug.--
</DELETED>
        <DELETED>    ``(1) In general.--The Secretary may approve an 
        application for approval of a fast track drug under section 
        505(b) or section 351 of the Public Health Service Act upon a 
        determination that the drug has an effect on a surrogate 
        endpoint that is reasonably likely to predict clinical 
        benefit.</DELETED>
        <DELETED>    ``(2) Limitation.--Approval under this subsection 
        may be subject to the requirement that the sponsor conduct 
        appropriate post-approval studies to validate the surrogate 
        endpoint or otherwise confirm the clinical benefit of the 
        drug.</DELETED>
<DELETED>    ``(c) Review of Incomplete Applications for Approval of a 
Fast Track Drug.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall, after 
        completion of the pivotal clinical trial for a fast track drug 
        under investigation, accept for filing and commence review of 
        an incomplete application for the drug's approval if the 
        application includes a schedule for submission of information 
        necessary to make the application complete and any fee that may 
        be required under section 736.</DELETED>
        <DELETED>    ``(2) Exception.--Any time period for review of 
        human drug applications agreed to by the Secretary under 
        section 736 shall not apply to applications submitted under 
        paragraph (1) until a completed application is 
        submitted.</DELETED>
<DELETED>    ``(d) Awareness Efforts.--The Secretary shall--</DELETED>
        <DELETED>    ``(1) develop and widely disseminate to 
        physicians, patient organizations, pharmaceutical and 
        biotechnology companies and other appropriate persons a 
        comprehensive description of the provisions applicable to fast 
        track drugs established under this section; and</DELETED>
        <DELETED>    ``(2) establish an ongoing program to encourage 
        the development and use of surrogate endpoints that are 
        reasonably likely to predict clinical benefit for all serious 
        and life-threatening conditions for which there exist 
        significant unmet medical needs.''.</DELETED>
<DELETED>    (b) Regulations.--Within 90 days after the date of 
enactment of this Act, the Secretary shall issue guidelines for fast 
track drugs that implement the requirements of section 561 of the 
Federal Food, Drug, and Cosmetic Act.</DELETED>

<DELETED>SEC. 615. MANUFACTURING CHANGES FOR DRUGS AND 
              BIOLOGICS.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
602, is further amended by adding at the end the following:</DELETED>

        <DELETED>``Subchapter E--Manufacturing Changes</DELETED>

<DELETED>``SEC. 751. MANUFACTURING CHANGES.</DELETED>

<DELETED>    ``(a) In General.--A change in the manufacture of a new 
drug, including a biological product, may be made in accordance with 
this section.</DELETED>
<DELETED>    ``(b) Changes.--</DELETED>
        <DELETED>    ``(1) Validation.--Before distributing a drug made 
        after a change in the manufacture of the drug from the 
        manufacturing process established in the approved new drug 
        application under section 505, or license application under 
        section 351 of the Public Health Service Act, the applicant 
        shall validate the effect of the change on the identity, 
        strength, quality, purity, and potency as the identity, 
        strength, quality, purity, and potency may relate to the safety 
        or effectiveness of the drug.</DELETED>
        <DELETED>    ``(2) Reports.--The applicant shall report a 
        change described in paragraph (1) to the Secretary and may 
        distribute a drug made after the change as follows:</DELETED>
                <DELETED>    ``(A)(i) Major manufacturing changes, 
                which are of a type determined by the Secretary to have 
                a substantial potential to adversely affect the 
                identity, strength, quality, purity, and potency as the 
                identity, strength, quality, purity, and potency may 
                relate to the safety or effectiveness of a drug, shall 
                be submitted to the Secretary in a supplemental 
                application and drugs made after such changes may not 
                be distributed until the Secretary approves the 
                supplemental application.</DELETED>
                <DELETED>    ``(ii) In this subparagraph, the term 
                `major manufacturing changes' means--</DELETED>
                        <DELETED>    ``(I) changes in the qualitative 
                        or quantitative formulation or the 
                        specifications in the approved marketing 
                        application (unless exempted by the 
                        Secretary);</DELETED>
                        <DELETED>    ``(II) changes which the Secretary 
                        determines by regulation or guidance require 
                        completion of an appropriate human study 
                        demonstrating equivalence to the drug 
                        manufactured before such changes; and</DELETED>
                        <DELETED>    ``(III) other changes which the 
                        Secretary determines by regulation or guidance 
                        have a substantial potential to adversely 
                        affect the safety or effectiveness of the 
                        drug.</DELETED>
                <DELETED>    ``(B)(i) As determined by the Secretary, 
                manufacturing changes other than major manufacturing 
                changes shall--</DELETED>
                        <DELETED>    ``(I) be made at any time and 
                        reported annually to the Secretary, with 
                        supporting data; or</DELETED>
                        <DELETED>    ``(II) be reported to the 
                        Secretary in a supplemental 
                        application.</DELETED>
                <DELETED>    ``(ii) In the case of changes made in 
                accordance with clause (i)(II);</DELETED>
                        <DELETED>    ``(I) the applicant may distribute 
                        the drug 30 days after the supplemental 
                        application is received by the Secretary unless 
                        the Secretary notifies the applicant within 
                        such 30-day period that prior approval of such 
                        supplemental application is required; 
                        and</DELETED>
                        <DELETED>    ``(II) the Secretary shall, after 
                        the notification to an applicant under 
                        subclause (I), approve or disapprove each such 
                        supplemental application.</DELETED>
                <DELETED>    ``(ii) The Secretary may determine types 
                of manufacturing changes after which distribution of a 
                drug may commence at the time of submission of such 
                supplemental application.''.</DELETED>
<DELETED>    (b) Existing Law.--The requirements of the Federal Food, 
Drug, and Cosmetic Act and the Public Health Service Act in effect on 
the date of enactment of this Act with respect to manufacturing changes 
shall remain in effect for--</DELETED>
        <DELETED>    (1) a period of 24 months after the date of the 
        enactment of this Act; or</DELETED>
        <DELETED>    (2) until the effective date of regulations 
        promulgated by the Secretary implementing section 751 of the 
        Federal Food, Drug, and Cosmetic Act,</DELETED>
<DELETED>whichever is sooner.</DELETED>

<DELETED>SEC. 616. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.</DELETED>

<DELETED>    Within 12 months after the date of enactment of this Act, 
the Secretary, through the Commissioner of Food and Drugs, shall issue 
guidance that describes when abbreviated study reports in lieu of full 
reports may be submitted with a new drug application for certain types 
of studies. Such guidance will describe the kinds of studies for which 
abbreviated reports are appropriate and the appropriate abbreviated 
report formats.</DELETED>

<DELETED>SEC. 617. FOOD CONTACT SUBSTANCES.</DELETED>

<DELETED>    (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 
348(a)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by striking at the end 
        ``or'';</DELETED>
        <DELETED>    (2) by striking the period at the end of paragraph 
        (2) and inserting ``; or'';</DELETED>
        <DELETED>    (3) by inserting after paragraph (2) the 
        following:</DELETED>
        <DELETED>    ``(3) in the case of a food additive as defined in 
        this Act that is a food contact substance, there is--</DELETED>
                <DELETED>    ``(A) in effect, and such substance and 
                the use of such substance are in conformity with, a 
                regulation issued under this section prescribing the 
                conditions under which such additive may be safely 
                used; or</DELETED>
                <DELETED>    ``(B) a notification submitted under 
                subsection (h) which is effective.''; and</DELETED>
        <DELETED>    (4) by striking the matter following paragraph (3) 
        (as added by paragraph (2)) and inserting the following flush 
        sentence:</DELETED>
<DELETED>``While such a regulation relating to a food additive, or such 
a notification under subsection (h) relating to a food additive that is 
a food contact substance , is in effect, and has not been revoked 
pursuant to subsection (j), a food shall not, by reason of bearing or 
containing such a food additive in accordance with the regulation or 
notification, be considered adulterated under section 
402(a)(1).''.</DELETED>
<DELETED>    (b) Notification for Food Contact Substances.--Section 409 
(21 U.S.C. 348), as amended by subsection (a), is further amended--
</DELETED>
        <DELETED>    (1) by redesignating subsections (h) and (i), as 
        subsections (i) and (j), respectively;</DELETED>
        <DELETED>    (2) by inserting after subsection (g) the 
        following:</DELETED>

 <DELETED>``notification relating to a food contact substance</DELETED>

<DELETED>    ``(h)(1) Subject to such regulations as may be promulgated 
under paragraph (3), a manufacturer or supplier of a food contact 
substance may, at least 120 days prior to the introduction or delivery 
for introduction into interstate commerce of the food contact 
substance, notify the Secretary of the identity and intended use of the 
food contact substance, and of the determination of the manufacturer or 
supplier that the intended use of such food contact substance is safe 
under the standard described in subsection (c)(3)(A). The notification 
shall contain the information that forms the basis of the 
determination, the fee required under paragraph (5), and all 
information required to be submitted by regulations promulgated by the 
Secretary.</DELETED>
<DELETED>    ``(2)(A) A notification submitted under paragraph (1) 
shall become effective 120 days after the date of receipt by the 
Secretary and the food contact substance may be introduced or delivered 
for introduction into interstate commerce, unless the Secretary makes a 
determination within the 120-day period that, based on the data and 
information before the Secretary, such use of the food contact 
substance has not been shown to be safe under the standard described in 
subsection (c)(3)(A), and informs the manufacturer or supplier of such 
determination.</DELETED>
<DELETED>    ``(B) A decision by the Secretary to object to a 
notification shall constitute final agency action subject to judicial 
review.</DELETED>
<DELETED>    ``(C) For purposes of this paragraph, `food contact 
substance' means the substance that is the subject of a notification 
submitted under paragraph (1), and does not include a similar or 
identical substance manufactured or prepared by a person other than the 
manufacturer identified in the notification.</DELETED>
<DELETED>    ``(3)(A) The process in this subsection shall be utilized 
for authorizing the marketing of a food contact substance except where 
the Secretary determines that submission and review of a petition under 
subsection (b) is necessary to provide adequate assurance of safety, or 
where the Secretary and any manufacturer or supplier agree that such 
manufacturer or supplier may submit a petition under subsection 
(b).</DELETED>
<DELETED>    ``(B) The Secretary is authorized to promulgate 
regulations to identify the circumstances in which a petition shall be 
filed under subsection (b), and shall consider criteria such as the 
probable consumption of such food contact substance and potential 
toxicity of the food contact substance in determining the circumstances 
in which a petition shall be filed under subsection (b).</DELETED>
<DELETED>    ``(4) The Secretary shall keep confidential any 
information provided in a notification under paragraph (1) for 120 days 
after receipt by the Secretary of the notification. After the 
expiration of such 120 days, the information shall be available to any 
interested party except for matters in the notification that is a trade 
secret or confidential commercial information.</DELETED>
<DELETED>    ``(5)(A) Each person that submits a notification regarding 
a food contact substance under this section shall be subject to the 
payment of a reasonable fee. The fee shall be based on the resources 
required to process the notification including reasonable 
administrative costs for such processing.</DELETED>
<DELETED>    ``(B) The Secretary shall conduct a study of the costs of 
administering the notification program established under this section 
and, on the basis of the results of such study, shall, within 18 months 
after the date of enactment of this subsection, promulgate regulations 
establishing the fee required by subparagraph (A).</DELETED>
<DELETED>    ``(C) A notification submitted without the appropriate fee 
is not complete and shall not become effective for the purposes of 
paragraph (3) until the appropriate fee is paid.</DELETED>
<DELETED>    ``(D) Fees collected pursuant to this subsection--
</DELETED>
        <DELETED>    ``(i) shall not be deposited as an offsetting 
        collection to the appropriations for the Department of Health 
        and Human Services;</DELETED>
        <DELETED>    ``(ii) shall be credited to the appropriate 
        account of the Food and Drug Administration; and</DELETED>
        <DELETED>    ``(iii) shall be available in accordance with 
        appropriation Acts until expended, without fiscal year 
        limitation.</DELETED>
<DELETED>    ``(6) In this section, the term `food contact substance' 
means any substance intended for use as a component of materials used 
in manufacturing, packing, packaging, transporting, or holding food if 
such use is not intended to have any technical effect in such 
food.'';</DELETED>
        <DELETED>    (3) in subsection (i), as so redesignated by 
        paragraph (1), by adding at the end the following: ``The 
        Secretary shall by regulation prescribe the procedure by which 
        the Secretary may deem a notification under subsection (h) to 
        no longer be effective.</DELETED>
        <DELETED>    (4) in subsection (j), as so redesignated by 
        paragraph (1), by striking ``subsections (b) to (h)'' and 
        inserting ``subsections (b) to (i)''.</DELETED>
<DELETED>    (c) Effective Date.--Notifications under section 409(h) of 
the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), 
may be submitted beginning 18 months after the date of the enactment of 
this Act.</DELETED>

<DELETED>SEC. 618. HEALTH CLAIMS OF FOOD PRODUCTS.</DELETED>

<DELETED>    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by 
adding at the end the following:</DELETED>
<DELETED>    ``(C) Notwithstanding the provisions of clauses (A)(i) and 
(B), a claim of the type described in subparagraph (1)(B) which is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause shall be authorized and may be made if--</DELETED>
        <DELETED>    ``(i) an authoritative scientific body of the 
        United States Government with official responsibility for 
        public health protection or research directly relating to human 
        nutrition (such as the National Institutes of Health or the 
        Centers for Disease Control and Prevention), the National 
        Academy of Sciences, or subdivisions of the scientific body or 
        the National Academy of Sciences, has published statements, 
        conclusions, or recommendations in effect recognizing that the 
        relationship between the nutrient and disease or health-related 
        condition to which the claim refers is supported by pertinent 
        scientific evidence; and</DELETED>
        <DELETED>    ``(ii) the manufacturer or distributor of the food 
        for which such claim is made has submitted to the Secretary at 
        least 90 days before the first introduction of such food into 
        interstate commerce a notice of claim, including a concise 
        description of the basis upon which such manufacturer or 
        distributor relied for determining that the requirements of 
        clause (i) have been satisfied.''.</DELETED>

<DELETED>SEC. 619. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.</DELETED>

<DELETED>    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended by inserting after section 505 the 
following:</DELETED>

<DELETED>``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.</DELETED>

<DELETED>    ``(a) Market Exclusivity for New Drugs.--If, prior to 
approval of an application that is submitted under section 505(b)(1) 
the Secretary determines that information relating to the use of a drug 
in the pediatric population may produce health benefits in that 
population, the Secretary makes a written request for pediatric studies 
(which may include a time frame for completing such studies), and such 
studies are completed within any such time frame and the reports 
thereof submitted in accordance with subsection (d)(2) or completed 
within any such time frame and the reports thereof are accepted in 
accordance with subsection (d)(3)--</DELETED>
        <DELETED>    ``(1)(A) the period during which an application 
        may not be submitted under subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 shall be five years and six months 
        rather than five years, and the references in subsections 
        (c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 to four years, 
        to forty-eight months, and to seven and one-half years shall be 
        deemed to be four and one-half years, fifty-four months, and 
        eight years, respectively; or</DELETED>
        <DELETED>    ``(B) the period of market exclusivity under 
        subsections (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and 
        (iv) of section 505 shall be three years and six months rather 
        than three years; and</DELETED>
        <DELETED>    ``(2)(A) if the drug is the subject of--</DELETED>
                <DELETED>    ``(i) a listed patent for which a 
                certification has been submitted under section 
                505(b)(2)(A)(ii) or section (j)(2)(A)(vii)(II) and for 
                which pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions), or</DELETED>
                <DELETED>    ``(ii) a listed patent for which a 
                certification has been submitted under section 
                505(b)(2)(A)(iii) or section 
                505(j)(2)(A)(vii)(III),</DELETED>
        <DELETED>the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions); or</DELETED>
        <DELETED>    ``(B) if the drug is the subject of a listed 
        patent for which a certification has been submitted under 
        section 505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), and 
        in the patent infringement litigation resulting from the 
        certification the court determines that the patent is valid and 
        would be infringed, the period during which an application may 
        not be approved under section 505(c)(3) or section 505(j)(4)(B) 
        shall be extended by a period of six months after the date the 
        patent expires (including any patent extensions).</DELETED>
<DELETED>    ``(b) Secretary To Develop List of Drugs for Which 
Additional Pediatric Information May Be Beneficial.--Not later than 180 
days after the date of enactment of this section, the Secretary, after 
consultation with experts in pediatric research (such as the American 
Academy of Pediatrics, the Pediatric Pharmacology Research Unit 
Network, and the United States Pharmacopoeia) shall develop and publish 
an initial list of approved drugs for which additional pediatric 
information may produce health benefits in the pediatric population. 
The Secretary shall annually update the list.</DELETED>
<DELETED>    ``(c) Market Exclusivity for Already-Marketed Drugs.--If 
the Secretary makes a written request for pediatric studies (which may 
include a time frame for completing such studies) concerning a drug 
identified in the list described in subsection (b) to the holder of an 
approved application under section 505(b)(1) for the drug, the holder 
agrees to the request, and the studies are completed within any such 
time frame and the reports thereof submitted in accordance with 
subsection (d)(2) or completed within any such time frame and the 
reports thereof accepted in accordance with subsection (d)(3)--
</DELETED>
        <DELETED>    ``(1)(A) the period during which an application 
        may not be submitted under subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 shall be five years and six months 
        rather than five years, and the references in subsections 
        (c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 to four years, 
        to forty-eight months, and to seven and one-half years shall be 
        deemed to be four and one-half years, fifty-four months, and 
        eight years, respectively; or</DELETED>
        <DELETED>    ``(B) the period of market exclusivity under 
        subsections (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and 
        (iv) of section 505 shall be three years and six months rather 
        than three years; and</DELETED>
        <DELETED>    ``(2)(A) if the drug is the subject of--</DELETED>
                <DELETED>    ``(i) a listed patent for which a 
                certification has been submitted under section 
                505(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) and for which 
                pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions), or</DELETED>
                <DELETED>    ``(ii) a listed patent for which a 
                certification has been submitted under section 
                505(b)(2)(A)(iii) or section 
                505(j)(2)(A)(vii)(III),</DELETED>
        <DELETED>the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions); or</DELETED>
        <DELETED>    ``(B) if the drug is the subject of a listed 
        patent for which a certification has been submitted under 
        section 505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), and 
        in the patent infringement litigation resulting from the 
        certification the court determines that the patent is valid and 
        would be infringed, the period during which an application may 
        not be approved under section 505(c)(3) or section 505(j)(4)(B) 
        shall be extended by a period of six months after the date the 
        patent expires (including any patent extensions).</DELETED>
<DELETED>    ``(d) Conduct of Pediatric Studies.--</DELETED>
        <DELETED>    ``(1) Agreement for studies.--The Secretary may, 
        pursuant to a written request for studies, after consultation 
        with--</DELETED>
                <DELETED>    ``(A) the sponsor of an application for an 
                investigational new drug under section 
                505(i),</DELETED>
                <DELETED>    ``(B) the sponsor of an application for a 
                drug under section 505(b)(1), or</DELETED>
                <DELETED>    ``(C) the holder of an approved 
                application for a drug under section 
                505(b)(1),</DELETED>
        <DELETED>agree with the sponsor or holder for the conduct of 
        pediatric studies for such drug.</DELETED>
        <DELETED>    ``(2) Written protocols to meet the studies 
        requirement.--If the sponsor or holder and the Secretary agree 
        upon written protocols for the studies, the studies requirement 
        of subsection (a) or (c) is satisfied upon the completion of 
        the studies and submission of the reports thereof in accordance 
        with the original written request and the written agreement 
        referred to in paragraph (1). Not later than 60 days after the 
        submission of the report of the studies, the Secretary shall 
        determine if such studies were or were not conducted in 
        accordance with the original written request and the written 
        agreement and reported in accordance with the requirements of 
        the Secretary for filing and so notify the sponsor or 
        holder.</DELETED>
        <DELETED>    ``(3) Other methods to meet the studies 
        requirement.--If the sponsor or holder and the Secretary have 
        not agreed in writing on the protocols for the studies, the 
        studies requirement of subsection (a) or (c) is satisfied when 
        such studies have been completed and the reports accepted by 
        the Secretary. Not later than 90 days after the submission of 
        the reports of the studies, the Secretary shall accept or 
        reject such reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or rejecting the 
        reports shall be to determine, within the 90 days, whether the 
        studies fairly respond to the written request, whether such 
        studies have been conducted in accordance with commonly 
        accepted scientific principles and protocols, and whether such 
        studies have been reported in accordance with the requirements 
        of the Secretary for filing.</DELETED>
<DELETED>    ``(e) Delay of Effective Date for Certain Applications; 
Period of Market Exclusivity.--If the Secretary determines that the 
acceptance or approval of an application under section 505(b)(2) or 
505(j) for a drug may occur after submission of reports of pediatric 
studies under this section, which were submitted prior to the 
expiration of the patent (including any patent extension) or market 
exclusivity protection, but before the Secretary has determined whether 
the requirements of subsection (d) have been satisfied, the Secretary 
shall delay the acceptance or approval under section 505(b)(2) or 
505(j), respectively, until the determination under subsection (d) is 
made, but such delay shall not exceed 90 days. In the event that 
requirements of this section are satisfied, the applicable period of 
market exclusivity referred to in subsection (a) or (c) shall be deemed 
to have been running during the period of delay.</DELETED>
<DELETED>    ``(f) Notice of Determinations on Studies Requirement.--
The Secretary shall publish a notice of any determination that the 
requirements of subsection (d) have been met and that submissions and 
approvals under section 505(b)(2) or (j) for a drug will be subject to 
the provisions of this section.</DELETED>
<DELETED>    ``(g) Definitions.--As used in this section, the term 
`pediatric studies' or `studies' means at least one clinical 
investigation (that, at the Secretary's discretion, may include 
pharmacokinetic studies) in pediatric age-groups in which a drug is 
anticipated to be used.</DELETED>
<DELETED>    ``(h) Limitation.--The holder of an approved application 
for a new drug that has already received six months of market 
exclusivity under subsection (a) or subsection (c) may, if otherwise 
eligible, obtain six months of market exclusivity under subsection 
(c)(1)(B) for a supplemental application, except that the holder is not 
eligible for exclusivity under subsection (c)(2).''</DELETED>
<DELETED>    ``(i) Sunset.--No period of market exclusivity shall be 
granted under this section based on studies commenced after January 1, 
2004. The Secretary shall conduct a study and report to Congress not 
later than January 1, 2003 based on the experience under the program. 
The study and report shall examine all relevant issues, including--
</DELETED>
        <DELETED>    ``(1) the effectiveness of the program in 
        improving information about important pediatric uses for 
        approved drugs;</DELETED>
        <DELETED>    ``(2) the adequacy of the incentive provided under 
        this section;</DELETED>
        <DELETED>    ``(3) the economic impact of the program; 
        and</DELETED>
        <DELETED>    ``(4) any suggestions for modification that the 
        Secretary deems appropriate.''.</DELETED>

          <DELETED>TITLE VII--FEES RELATING TO DRUGS</DELETED>

<DELETED>SEC. 701. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Prescription Drug Users 
Fee Reauthorization Act of 1997''.</DELETED>

<DELETED>SEC. 702. FINDINGS.</DELETED>

<DELETED>    Congress finds that--</DELETED>
        <DELETED>    (1) prompt approval of safe and effective new 
        drugs is critical to the improvement of the public health so 
        that patients may enjoy the benefits provided by the drugs to 
        treat and prevent illness and disease;</DELETED>
        <DELETED>    (2) the public health will be served by making 
        additional funds available for the purpose of augmenting the 
        resources of the Food and Drug Administration that are devoted 
        to the review of human drug applications;</DELETED>
        <DELETED>    (3) the provisions added by the Prescription Drug 
        User Fee Act of 1992, has been successful in substantially 
        reducing review times for human drug applications and should 
        be--</DELETED>
                <DELETED>    (A) reauthorized for an additional 5 
                years, with certain technical improvements; 
                and</DELETED>
                <DELETED>    (B) carried out by the Food and Drug 
                Administration with new commitments to implement more 
                ambitious and comprehensive improvements in regulatory 
                processes of the Food and Drug Administration; 
                and</DELETED>
        <DELETED>    (4) the fees authorized by amendments made in this 
        title will be dedicated toward expediting the drug development 
        process and the review of human drug applications as set forth 
        in the goals identified in the letters of 
        </DELETED>______________<DELETED>, and 
        </DELETED>______________<DELETED>, from the Secretary of Health 
        and Human Services to the Chairman of the Committee on Commerce 
        of the House of Representatives and the Chairman of Committee 
        on Labor and Human Resources Committee of the Senate, as set 
        forth at </DELETED>____ <DELETED>Cong. Rec. </DELETED>________ 
        <DELETED>(daily ed. </DELETED>__________<DELETED>, 
        1997).</DELETED>

<DELETED>SEC. 703. DEFINITIONS.</DELETED>

<DELETED>    Section 735 (21 U.S.C. 379g) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) by striking ``Service Act, and'' and 
                inserting ``Service Act,''; and</DELETED>
                <DELETED>    (B) by striking ``September 1, 1992.'' and 
                inserting the following: ``September 1, 1992, does not 
                include an application for a biological product that is 
                licensed for further manufacturing use only, and does 
                not include an application or supplement submitted by a 
                State or Federal Government entity for a drug or 
                biological product that is not distributed 
                commercially. Such term does include an application for 
                a large volume biological product intended for single 
                dose injection for intravenous use or 
                infusion.'';</DELETED>
        <DELETED>    (2) in paragraph (3)--</DELETED>
                <DELETED>    (A) by striking ``Service Act, and'' and 
                inserting ``Service Act,''; and</DELETED>
                <DELETED>    (B) by striking ``September 1, 1992.'' and 
                inserting the following: ``September 1, 1992, does not 
                include a biological product that is licensed for 
                further manufacturing use only, and does not include a 
                biological product that is not distributed commercially 
                and is the subject of a supplement or application 
                submitted by a State or Federal Government entity. Such 
                term does include a large volume biological product 
                intended for single dose injection for intravenous use 
                or infusion.'';</DELETED>
        <DELETED>    (3) in paragraph (4), by striking ``without'' and 
        inserting ``without substantial'';</DELETED>
        <DELETED>    (4) in paragraph (7)(A), by striking ``employees 
        under contract'' and all that follows through 
        ``Administration,'' and inserting ``contractors of the Food and 
        Drug Administration,'';</DELETED>
        <DELETED>    (5) in paragraph (8)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) by striking ``August of'' and 
                        inserting ``April of''; and</DELETED>
                        <DELETED>    (ii) by striking ``August 1992'' 
                        and inserting ``April 1992''; and</DELETED>
                <DELETED>    (B) by striking subparagraph (B) and 
                inserting the following:</DELETED>
                <DELETED>    ``(B) the total percentage increase for 
                such fiscal year since fiscal year 1997 in basic pay 
                under the General Schedule in accordance with section 
                5332 of title 5, United States Code, as adjusted by any 
                locality-based comparability payment pursuant to 
                section 5304 of such title for Federal employees 
                stationed in the District of Columbia.''; and</DELETED>
        <DELETED>    (6) by adding at the end the following:</DELETED>
        <DELETED>    ``(9) The term `affiliate' means, directly or 
        indirectly,--</DELETED>
                <DELETED>    ``(A) 1 business entity controls, or has 
                the power to control, the other business entity; 
                or</DELETED>
                <DELETED>    ``(B) a third party controls, or has power 
                to control both of the business entities described in 
                subparagraph (A).''.</DELETED>

<DELETED>SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.</DELETED>

<DELETED>    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
amended--</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) by striking subparagraph (B) and 
                inserting the following:</DELETED>
                <DELETED>    ``(B) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission of the 
                application or supplement.'';</DELETED>
                <DELETED>    (B) in subparagraph (D)--</DELETED>
                        <DELETED>    (i) in the subparagraph heading, 
                        by striking ``not accepted'' and inserting 
                        ``refused'';</DELETED>
                        <DELETED>    (ii) by striking ``50 percent'' 
                        and inserting ``75 percent'';</DELETED>
                        <DELETED>    (iii) by striking ``subparagraph 
                        (B)(i)'' and inserting ``subparagraph (B); 
                        and</DELETED>
                        <DELETED>    (iv) by striking ``not accepted'' 
                        and inserting ``refused''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(E) Exception for designated orphan drug 
                or indication.--A human drug application for a 
                prescription drug product that has been designated as a 
                drug for a rare disease or condition pursuant to 
                section 526, or a supplement proposing to include a new 
                indication for a rare disease or condition pursuant to 
                section 526, shall not be assessed a fee under 
                subparagraph (A), unless the human drug application 
                includes indications for other than rare diseases or 
                conditions.</DELETED>
                <DELETED>    ``(F) Exception for applications and 
                supplements for pediatric indications.--A human drug 
                application or supplement that includes an indication 
                for use in pediatric populations shall be assessed a 
                fee under subparagraph (A) only if--</DELETED>
                        <DELETED>    ``(i) the application is for 
                        initial approval for use in a pediatric 
                        population; or</DELETED>
                        <DELETED>    ``(ii) the application or 
                        supplement is for approval for use in pediatric 
                        and non-pediatric populations.</DELETED>
                <DELETED>    ``(G) Refund of fee if application 
                withdrawn.--If an application or supplement is 
                withdrawn after the application or supplement is filed, 
                the Secretary may waive and refund the fee or a portion 
                of the fee if no substantial work was performed on the 
                application or supplement after the application or 
                supplement was filed. The Secretary shall have the sole 
                discretion to waive and refund a fee or a portion of 
                the fee under this subparagraph. A determination by the 
                Secretary concerning a waiver or refund under this 
                paragraph shall not be reviewable.'';</DELETED>
        <DELETED>    (2) in paragraph (2)(A), by striking ``505(j), 
        and'' and inserting the following: ``505(j) or under an 
        abbreviated new drug application pursuant to regulations in 
        effect prior to the implementation of the Drug Price 
        Competition and Patent Term Restoration Act of 1984, or a 
        product approved under an application under section 507 that is 
        abbreviated, and''; and</DELETED>
        <DELETED>    (3) in paragraph (3)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) in clause (i), by striking 
                        ``is listed'' and inserting ``has been 
                        submitted for listing''; and</DELETED>
                        <DELETED>    (ii) by striking ``Such fee shall 
                        be payable'' and all that follows through 
                        ``section 510.'' and inserting the following: 
                        ``Such fee shall be payable for the fiscal year 
                        in which the product is first submitted for 
                        listing under section 510 or for relisting if 
                        the product has been withdrawn from listing or 
                        relisted and after such fee is paid for that 
                        fiscal year, such fee shall be payable on or 
                        before January 31 of each year. Such fee shall 
                        be paid only once for each product for the 
                        fiscal year in which a fee is payable.''; 
                        and</DELETED>
                <DELETED>    (B) in subparagraph (B), by striking 
                ``505(j).'' and inserting the following: ``505(j) or 
                under an abbreviated new drug application pursuant to 
                regulations in effect prior to implementation of the 
                Drug Price Competition and Patent Term Restoration Act 
                of 1984, or a product approved under an application 
                under section 507 that is abbreviated.''</DELETED>
<DELETED>    (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
amended to read as follows:</DELETED>
<DELETED>    ``(b) Fee Amounts.--Except as provided in subsections (c), 
(d), (f), and (g), the fees required under subsection (a) shall be 
determined and assessed as follows:</DELETED>
        <DELETED>    ``(1) Application fee.--The application fee under 
        subsection (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, 
        $256,338 in fiscal years 1999 and 2000, $267,606 in fiscal year 
        2001, and $258,451 in fiscal year 2002.</DELETED>
        <DELETED>    ``(2) Supplement fee.--The supplement fee under 
        subsection (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, 
        $128,169 in fiscal years 1999 and 2000, $133,803 in fiscal year 
        2001, and $129,226 in fiscal year 2002.</DELETED>
        <DELETED>    ``(3) Fee revenues for establishment fees.--The 
        total fee revenues to be collected in establishment fees under 
        subsection (a)(2) shall be $35,600,000 in fiscal year 1998, 
        $36,400,000 in fiscal years 1999 and 2000, $38,000,000 in 
        fiscal year 2001, and $36,700,000 in fiscal year 
        2002.</DELETED>
        <DELETED>    ``(4) Total fee revenues for product fees.--The 
        total fee revenues to be collected in product fees under 
        subsection (a)(3) in a fiscal year shall be equal to the total 
        fee revenues collected for establishment fees under subsection 
        (a)(2) in that fiscal year.''.</DELETED>
<DELETED>    (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 
379h(c)) is amended--</DELETED>
        <DELETED>    (1) in the subsection heading, by striking 
        ``Increases and'';</DELETED>
        <DELETED>    (2) in paragraph (1)--</DELETED>
                <DELETED>    (A) by striking ``(1) Revenue'' and all 
                that follows through ``increased by the Secretary'' and 
                inserting the following: ``(1) Inflation adjustment.--
                The fees and total fee revenues established in 
                subsection (b) shall be adjusted by the 
                Secretary'';</DELETED>
                <DELETED>    (B) in subparagraph (A), by striking 
                ``increase'' and inserting ``change'';</DELETED>
                <DELETED>    (C) in subparagraph (B), by striking 
                ``increase'' and inserting ``change''; and</DELETED>
                <DELETED>    (D) by adding at the end the following 
                flush sentence:</DELETED>
        <DELETED>``The adjustment made each fiscal year by this 
        subsection will be added on a compounded basis to the sum of 
        all adjustments made each fiscal year after fiscal year 1997 
        under this provision.'';</DELETED>
        <DELETED>    (3) in paragraph (2), by striking ``October 1, 
        1992,'' and all that follows through ``such schedule.'' and 
        inserting the following: ``September 30, 1997, adjust the 
        establishment and product fees described in subsection (b) so 
        that the revenues collected from each such fee category shall 
        be set to be equal to the revenues collected from the 
        application and supplement fee category.''; and</DELETED>
        <DELETED>    (4) in paragraph (3), by striking ``paragraph 
        (2)'' and inserting ``this subsection''.</DELETED>
<DELETED>    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
379h(d)) is amended--</DELETED>
        <DELETED>    (1) by redesignating paragraphs (1), (2), (3), and 
        (4) as subparagraphs (A), (B), (C), and (D), respectively and 
        indenting appropriately;</DELETED>
        <DELETED>    (2) by striking ``The Secretary shall grant a'' 
        and all that follows through ``finds that--'' and inserting the 
        following:</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall grant a 
        waiver from or a reduction of 1 or more fees under subsection 
        (a) where the Secretary finds that--''</DELETED>
        <DELETED>    (3) in subparagraph (C) (as so redesignated by 
        paragraph (1)), by striking ``, or'' and inserting a 
        comma;</DELETED>
        <DELETED>    (4) in subparagraph (D) (as so redesignated by 
        paragraph (1)), by striking the period and inserting ``, 
        and'';</DELETED>
        <DELETED>    (5) by inserting after subparagraph (D) (as so 
        redesignated by paragraph (1)) the following:</DELETED>
                <DELETED>    ``(E) the applicant is a small business 
                submitting its first human drug application to the 
                Secretary for review.''; and</DELETED>
        <DELETED>    (6) by striking ``In making the finding in 
        paragraph (3),'' and all that follows through ``standard 
        costs.'' inserting the following:</DELETED>
        <DELETED>    ``(2) Use of standard costs.--In making the 
        finding in subparagraph (C), the Secretary may use standard 
        costs.</DELETED>
        <DELETED>    ``(3) Rules relating to small businesses.--
        </DELETED>
                <DELETED>    ``(A) Definition.--For the purpose of 
                paragraph (1)(E), a small business is an entity that 
                has fewer than 500 employees, including employees of 
                affiliates.</DELETED>
                <DELETED>    ``(B) Waiver of application fee.--The 
                Secretary shall waive under paragraph (1)(E), the 
                application fee for the first human drug application 
                that a small business or its affiliate submits to the 
                Secretary for review. After a small business or its 
                affiliate is granted such a waiver, the small business 
                or its affiliate shall pay--</DELETED>
                        <DELETED>    ``(i) application fees for all 
                        subsequent human drug applications submitted to 
                        the Secretary for review in the same manner as 
                        an entity that does not qualify as a small 
                        business; and</DELETED>
                        <DELETED>    ``(ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review in the 
                        same manner as an entity that does not qualify 
                        as a small business.''.</DELETED>
<DELETED>    (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 
379g(f)(1)) is amended--</DELETED>
        <DELETED>    (1) by striking ``fiscal year 1993'' and inserting 
        ``fiscal year 1997''; and</DELETED>
        <DELETED>    (2) by striking ``fiscal year 1992'' and inserting 
        ``fiscal year 1997 (excluding the amount of fees appropriated 
        for such fiscal year)''.</DELETED>
<DELETED>    (f) Crediting and Availability of Fees.--Section 736(g) 
(21 U.S.C. 379g(g)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by adding at the end the 
        following: ``Such sums as may be necessary may be transferred 
        from the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the review of human drug 
        applications within the meaning of subsection 
        735(6).'';</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) in subparagraph (A), by striking 
                ``Acts'' and inserting ``Acts, or otherwise made 
                available for obligation,''; and</DELETED>
                <DELETED>    (B) in subparagraph (B), by striking 
                ``over such costs for fiscal year 1992'' and inserting 
                ``over such costs, excluding costs paid from fees 
                collected under this section, for fiscal year 1997''; 
                and</DELETED>
        <DELETED>    (3) by striking paragraph (3) and inserting the 
        following:</DELETED>
        <DELETED>    ``(3) Authorization of Appropriations.--There is 
        authorized to be appropriated for fees under this section--
        </DELETED>
                <DELETED>    ``(A) $106,800,000 for fiscal year 
                1998,</DELETED>
                <DELETED>    ``(B) $109,200,000 for fiscal year 
                1999,</DELETED>
                <DELETED>    ``(C) $109,200,000 for fiscal year 
                2000,</DELETED>
                <DELETED>    ``(D) $114,000,000 for fiscal year 2001, 
                and</DELETED>
                <DELETED>    ``(E) $110,100,000 for fiscal year 
                2002,</DELETED>
        <DELETED>as adjusted to reflect adjustments in the total fee 
        revenues made under this section and changes in the total 
        amounts collected by application, supplement, establishment, 
        and products fees.''.</DELETED>
<DELETED>    (g) Requirement for Written Requests for Waivers and 
Fees.--Section 736 (21 U.S.C. 379h) is amended by--</DELETED>
        <DELETED>    (1) redesignating subsection (i) as subsection 
        (j); and</DELETED>
        <DELETED>    (2) by inserting after subsection (h) the 
        following:</DELETED>
<DELETED>    ``(i) Written Requests for waivers and refunds.--To 
qualify for consideration for a waiver under subsection (d), or for a 
refund of any fee collected in accordance with subsection (a), a person 
must submit to the Secretary a written request for such waiver or 
refund not later than 180 days after such fee is due. Any requests for 
waivers, refunds, or exceptions must be submitted in writing to the 
Secretary within 1 year after the date of enactment of this 
subsection.''.</DELETED>

<DELETED>SEC. 705. ANNUAL REPORTS.</DELETED>

<DELETED>    (a) First Report.--Not later than 60 days after the end of 
each fiscal year during which fees are collected under part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379g et seq.), the Secretary of Health and Human Services 
shall prepare and submit to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letter 
described in section 702(4) during such fiscal year and the future 
plans of the Food and Drug Administration for meeting the 
goals.</DELETED>
<DELETED>    (b) Second Report.--Not later than 120 days after the end 
of each fiscal year during which fees are collected under the part 
described in subsection (a), the Secretary of Health and Human Services 
shall prepare and submit to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate a report on the implementation of the authority for such fees 
during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected during such fiscal year for which 
the report is made.</DELETED>

<DELETED>SEC. 706. EFFECTIVE DATE.</DELETED>

<DELETED>    The amendments made by this title shall take effect 
October 1, 1997.</DELETED>

<DELETED>SEC. 707. TERMINATION OF EFFECTIVENESS.</DELETED>

<DELETED>    The amendments made by sections 703 and 704 cease to be 
effective October 1, 2002 and section 4 ceases to be effective 120 days 
after such date.</DELETED>

              <DELETED>TITLE VIII--MISCELLANEOUS</DELETED>

<DELETED>SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.</DELETED>

<DELETED>    Section 510(i) (21 U.S.C. 360(i)) is amended to read as 
follows:</DELETED>
<DELETED>    ``(i)(1) Any establishment within any foreign country 
engaged in the manufacture, preparation, propagation, compounding, or 
processing of a drug or drugs or a device or devices that are imported 
or offered for the import into the United States shall register with 
the Secretary the name and place of business of the establishment and 
the name of the United States agent for the establishment.</DELETED>
<DELETED>    ``(2) The establishment shall also provide the information 
required by subsection (j).</DELETED>
<DELETED>    ``(3) The Secretary is authorized to enter into 
cooperative arrangements with foreign countries to ensure that adequate 
and effective means are available for purposes of determining, from 
time to time, whether drugs or devices manufactured, prepared, 
propagated, compounded, or processed in an establishment in paragraph 
(1), if imported or offered for import into the United States, shall be 
refused admission on any of the grounds set forth in section 801(a) of 
this Act.</DELETED>

<DELETED>SEC. 802. ELIMINATION OF CERTAIN LABELING 
              REQUIREMENTS.</DELETED>

<DELETED>    (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 
353(b)(4)) is amended to read as follows:</DELETED>
<DELETED>    ``(4)(A) A drug which is subject to paragraph (1) shall be 
deemed to be misbranded if at any time prior to dispensing the label of 
the drug fails to bear, at a minimum, the symbol `Rx only'.''</DELETED>
<DELETED>    ``(B) A drug to which paragraph (1) does not apply shall 
be deemed to be misbranded if at any time prior to dispensing the label 
of the drug bears the symbol described in subparagraph (B).</DELETED>
<DELETED>    (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
repealed.</DELETED>

<DELETED>SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.</DELETED>

<DELETED>    Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (1), in the fifth sentence, by 
        striking ``paragraphs (1) and (2) of section 801(e)'' and 
        inserting ``subparagraphs (A) and (B) of section 801(e)(1)''; 
        and</DELETED>
        <DELETED>    (2) by inserting after the fifth sentence the 
        following: ``Any person seeking to export an imported article 
        pursuant to any of the provisions of this subsection shall 
        establish that the article was intended for export at the time 
        the article entered commerce.''</DELETED>

<DELETED>SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD 
              PROGRAM.</DELETED>

<DELETED>    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
206, is further amended by adding at the end the following:</DELETED>

<DELETED>``SEC. 908. RESEARCH TRAINING AWARD PROGRAM.</DELETED>

<DELETED>    ``(a) In General.--The Secretary, acting through the 
Commissioner of Food and Drugs, may, directly or through grants, 
contracts, or cooperative agreements, conduct and support research 
training in regulatory scientific programs by predoctoral and 
postdoctoral scientists and physicians, including the use of 
fellowships.</DELETED>
<DELETED>    ``(b) Limitation on participation.--A recipient of a 
fellowship under subsection (a) may not be an employee of the Federal 
Government.</DELETED>
<DELETED>    ``(c) Special Rule.--The Secretary, acting through the 
Commissioner of Food and Drugs, may support the provision of assistance 
for fellowships through a Cooperative Research and Development 
Agreement.''.</DELETED>

<DELETED>SEC. 805. ENFORCEMENT AUTHORITY FOR SPECIAL 
              CONTROLS.</DELETED>

<DELETED>    (a) Adulterated Provisions.--Section 501(e) as amended by 
section 205, is amended by striking subparagraph (1) and inserting the 
following: ``(1) If it is, or purports to be or is represented as, a 
device which is subject to a performance standard or a special control 
established under section 514, unless such device is in all respects in 
conformity with such standard or special control.''.</DELETED>
<DELETED>    (b) Misbranded Provisions.--Section 502(s) (21 U.S.C. 
352(s)) is amended to read as follows:</DELETED>
<DELETED>    ``(s) If it is a device subject to a performance standard 
or a special control established or recognized under section 514, 
unless the device bears such labeling as may be prescribed in such 
standard or special control.''.</DELETED>

<DELETED>SEC. 806. DEVICE SAMPLES.</DELETED>

<DELETED>    (a) Recall Authority.--</DELETED>
        <DELETED>    (1) In general.--Section 518(e)(2) (21 U.S.C. 
        360h(e)(2)) is amended by adding at the end the 
        following:</DELETED>
<DELETED>    ``(C) If the Secretary issues an amended order under 
subparagraph (A), the Secretary may require the person subject to the 
order to submit samples of such device and of components of the device 
as the Secretary may reasonably require, except that where the 
submission of such samples is impracticable or unduly burdensome, the 
requirement of this subparagraph may be met by the submission of 
complete information concerning the location of 1 or more such devices 
readily available for examination and testing.''.</DELETED>
        <DELETED>    (2) Technical amendment.--Section 518(e)(2)(A)) is 
        amended by striking ``subparagraphs (B) and (C)'' and inserting 
        ``subparagraph (B)''.</DELETED>
<DELETED>    (b) Records and Reports on Devices.--Section 519(a) (21 
U.S.C. 360(a)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (8), by striking ``; and'' and 
        inserting a semicolon;</DELETED>
        <DELETED>    (2) in paragraph (9), by striking ``made.'' and 
        inserting ``made; and'';</DELETED>
        <DELETED>    (3) by inserting after paragraph (9) the 
        following:</DELETED>
        <DELETED>    ``(10) may reasonably require a manufacturer, 
        importer, or distributor to submit samples of a device and of 
        components of the device that may have caused or contributed to 
        a death or serious injury, except that where the submission of 
        such samples is impracticable or unduly burdensome, the 
        requirement of this paragraph may be met by the submission of 
        complete information concerning the location of 1 or more such 
        devices readily available for examination and 
        testing.''.</DELETED>

<DELETED>SEC. 807. INTERSTATE COMMERCE.</DELETED>

<DELETED>    (a) Findings.--Congress finds that--</DELETED>
        <DELETED>    (1) in order to make effective the regulation of 
        interstate commerce involving devices, foods, drugs, and 
        cosmetics, it is necessary to impose equivalent requirements on 
        intrastate commerce involving adulterated and misbranded 
        devices, foods, drugs, and cosmetics as imposed on interstate 
        commerce in such articles;</DELETED>
        <DELETED>    (2) without the presumption of a connection with 
        interstate commerce, intrastate commerce involving adulterated 
        and misbranded devices, foods, drugs, and cosmetics would 
        discriminate against and depress interstate commerce in 
        devices, foods, drugs, and cosmetics, and adversely burden, 
        obstruct, and affect such interstate commerce; and</DELETED>
        <DELETED>    (3) transactions involving adulterated and 
        misbranded devices, foods, drugs, and cosmetics constitute a 
        class of activities that have a deleterious effect on the 
        public health and welfare.</DELETED>
<DELETED>    (b) Definition.--Section 201(b) (21 U.S.C. 321(b)) is 
amended--</DELETED>
        <DELETED>    (1) by striking ``and (2) commerce'' and inserting 
        ``(2) commerce'';</DELETED>
        <DELETED>    (2) by inserting before the period the following: 
        ``, and (3) commerce involving any article or class of 
        activities that directly or indirectly affects interstate 
        commerce pursuant to section 709''.</DELETED>
<DELETED>    (c) Seizure.--Section 304(a)(2)(D) (21 U.S.C. 
334(a)(2)(D)) is amended to read as follows: ``(D) Any adulterated or 
misbranded device, food, drug, or cosmetic.''.</DELETED>
<DELETED>    (d) Presumption.--Section 709 (21 U.S.C. 379a) is amended 
by striking ``a device'' and inserting ``a device, food, drug, or 
cosmetic''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration 
Modernization and Accountability Act of 1997''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.

                   TITLE I--IMPROVING PATIENT ACCESS

Sec. 101. Mission of the Food and Drug Administration.
Sec. 102. Expedited access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.

         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition 
                            agreements and global harmonization 
                            efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.

          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.

           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.
Sec. 405. Definition of a day for purposes of product review.
Sec. 406. Certainty of review timeframes.
Sec. 407. Limitations on initial classification determinations.
Sec. 408. Clarification with respect to a general use and specific use 
                            of a device.
Sec. 409. Clarification of the number of required clinical 
                            investigations for approval.
Sec. 410. Prohibited acts.

                   TITLE V--IMPROVING ACCOUNTABILITY

Sec. 501. Agency plan for statutory compliance and annual report.

     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain classes of devices from premarket 
                            notification requirement.
Sec. 604. Evaluation of automatic class III designation.
Sec. 605. Secretary's discretion to track devices.
Sec. 606. Secretary's discretion to conduct postmarket surveillance.
Sec. 607. Reporting.
Sec. 608. Pilot and small-scale manufacture.
Sec. 609. Requirements for radiopharmaceuticals.
Sec. 610. Modernization of regulation of biological products.
Sec. 611. Approval of supplemental applications for approved products.
Sec. 612. Health care economic information.
Sec. 613. Expediting study and approval of fast track drugs.
Sec. 614. Manufacturing changes for drugs and biologics.
Sec. 615. Data requirements for drugs and biologics.
Sec. 616. Food contact substances.
Sec. 617. Health claims for food products.
Sec. 618. Pediatric studies marketing exclusivity.
Sec. 619. Positron emission tomography.

                   TITLE VII--FEES RELATING TO DRUGS

Sec. 701. Short title.
Sec. 702. Findings.
Sec. 703. Definitions.
Sec. 704. Authority to assess and use drug fees.
Sec. 705. Annual reports.
Sec. 706. Effective date.
Sec. 707. Termination of effectiveness.

                       TITLE VIII--MISCELLANEOUS

Sec. 801. Registration of foreign establishments.
Sec. 802. Elimination of certain labeling requirements.
Sec. 803. Clarification of seizure authority.
Sec. 804. Intramural research training award program.
Sec. 805. Device samples.
Sec. 806. Interstate commerce.
Sec. 807. National uniformity for nonprescription drugs and cosmetics.
Sec. 808. Information program on clinical trials for serious or life-
                            threatening diseases.
Sec. 809. Application of Federal law to the practice of pharmacy 
                            compounding.

SEC. 3. REFERENCES.

    Except as otherwise expressly provided, wherever in this Act an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.).

                   TITLE I--IMPROVING PATIENT ACCESS

SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION.

    Section 903 (21 U.S.C. 393) is amended--
            (1) by redesignating subsections (b) and (c) as subsections 
        (c) and (d), respectively; and
            (2) by inserting after subsection (a) the following:
    ``(b) Mission.--
            ``(1) In general.--The Administration shall protect the 
        public health by ensuring that--
                    ``(A) foods are safe, wholesome, sanitary, and 
                properly labeled;
                    ``(B) human and veterinary drugs are safe and 
                effective;
                    ``(C) there is reasonable assurance of safety and 
                effectiveness of devices intended for human use;
                    ``(D) cosmetics are safe; and
                    ``(E) public health and safety are protected from 
                electronic product radiation.
            ``(2) Special rules.--The Administration shall promptly and 
        efficiently review clinical research and take appropriate 
        action on the marketing of regulated products in a manner that 
        does not unduly impede innovation or product availability. The 
        Administration shall participate with other countries to reduce 
        the burden of regulation, to harmonize regulatory requirements, 
        and to achieve appropriate reciprocal arrangements with other 
        countries.''.

SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES.

    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end 
the following:

          ``Subchapter D--Unapproved Therapies and Diagnostics

``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.

    ``(a) In General.--Any person, acting through a physician licensed 
in accordance with State law, may request from a manufacturer or 
distributor, and any manufacturer or distributor may provide to a 
person after compliance with the provisions of this section, an 
investigational drug (including a biological product) or 
investigational device for the diagnosis, monitoring, or treatment of a 
serious disease or condition, or any other disease or condition 
designated by the Secretary as appropriate for expanded access under 
this section if--
            ``(1) the licensed physician determines that the person has 
        no comparable or satisfactory alternative therapy available to 
        diagnose, monitor, or treat the disease or condition involved;
            ``(2) the licensed physician determines that the risk to 
        the person from the investigational drug or investigational 
        device is not greater than the risk from the disease or 
        condition;
            ``(3) the Secretary determines that an exemption for the 
        investigational drug or investigational device is in effect 
        under a regulation promulgated pursuant to section 505(i) or 
        520(g) and the sponsor of the drug or device and investigators 
        comply with such regulation;
            ``(4) the Secretary determines that the manufacturer of the 
        investigational drug or investigational device is actively 
        pursuing marketing approval with due diligence;
            ``(5) the Secretary determines that expanded access to the 
        investigational drug or investigational device will not 
        interfere with adequate enrollment of patients by the 
        investigator in the ongoing clinical investigation of the 
        investigational drug or investigational device authorized under 
        section 505(i) or 520(g); and
            ``(6) the Secretary determines that there is sufficient 
        evidence of safety and effectiveness to support the expanded 
        use of the investigational drug or investigational device in 
        accordance with this section.
    ``(b) Protocols.--A manufacturer or distributor may submit to the 
Secretary 1 or more expanded access protocols covering expanded access 
use of a drug or device described in subsection (a). The protocols 
shall be subject to the provisions of section 505(i) or 520(g) and may 
include any form of use of the drug or device outside a clinical 
investigation, prior to approval of the drug or device for marketing, 
including protocols for treatment use, emergency use, or uncontrolled 
trials, and single patient protocols. If the request for expanded 
access to an investigational drug or investigational device is intended 
for a single patient only, the Secretary may waive the requirements of 
paragraphs (3) and (4) of subsection (a) and accept a submission under 
section 505(i) or 520(g) for an exemption for the investigational drug 
or investigational device for the single patient use. In the case of an 
emergency that does not allow sufficient time for a submission under 
section 505(i) or 520(g), the Secretary may, prior to the submission, 
authorize the shipment of the investigational drug or investigational 
device for a single patient use.
    ``(c) Notification of Availability.--The Secretary shall inform 
national, State, and local medical associations and societies, 
voluntary health associations, and other appropriate persons about the 
availability of an investigational drug or investigational device under 
expanded access protocols submitted under this section, except that 
this subsection shall not apply to expanded access protocols for single 
patient use.
    ``(d) Termination.--The Secretary may at anytime terminate expanded 
access provided under subsection (a) for an investigational drug or 
investigational device if the requirements under this section are no 
longer met.''.

SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.

    Section 520(m) (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (2), by adding at the end the following 
        flush sentences:
``The request shall be in the form of an application submitted to the 
Secretary. Not later than 60 days after the date of the receipt of the 
application, the Secretary shall issue an order approving or denying 
the application.'';
            (2) in paragraph (4)--
                    (A) in subparagraph (B), by inserting after 
                ``(2)(A)'' the following: ``, unless a physician 
                determines that waiting for such an approval from an 
                institutional review committee will cause harm or death 
                to a patient, and makes a good faith effort to obtain 
                the approval, and does not receive a timely response 
                from an institutional review committee on the request 
                of the physician for approval to use the device for 
                such treatment or diagnosis''; and
                    (B) by adding at the end the following flush 
                sentences:
``In a case in which a physician described in subparagraph (B) uses a 
device without an approval from an institutional review committee, the 
physician shall, after the use of the device, notify the chairperson of 
the institutional review committee of such use. Such notification shall 
include the identification of the patient involved, the date on which 
the device was used, and the reason for the use.''; and
            (3) by striking paragraph (5) and inserting the following:
    ``(5) The Secretary may require a person granted an exemption under 
paragraph (2) to demonstrate continued compliance with the requirements 
of this subsection if the Secretary believes such demonstration to be 
necessary to protect the public health or if the Secretary has reason 
to believe that the criteria for the exemption are no longer met.''.

         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

SEC. 201. INTERAGENCY COLLABORATION.

    Section 903(b) (21 U.S.C. 393(b)), as added by section 101(2), is 
amended by adding at the end the following:
            ``(3) Interagency collaboration.--The Secretary shall 
        implement programs and policies that will foster collaboration 
        between the Administration, the National Institutes of Health, 
        and other science-based Federal agencies, to enhance the 
        scientific and technical expertise available to the Secretary 
        in the conduct of the duties of the Secretary with respect to 
        the development, clinical investigation, evaluation, and 
        postmarket monitoring of emerging medical therapies, including 
        complementary therapies, and advances in nutrition and food 
        science.''.

SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION 
              AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.

    It is the sense of the Committee on Labor and Human Resources of 
the Senate that--
            (1) the Secretary of Health and Human Services should 
        support the Office of the United States Trade Representative, 
        in consultation with the Secretary of Commerce, in efforts to 
        move toward the acceptance of mutual recognition agreements 
        relating to the regulation of drugs, biological products, 
        devices, foods, food additives, and color additives, and the 
        regulation of good manufacturing practices, between the 
        European Union and the United States;
            (2) the Secretary of Health and Human Services should 
        regularly participate in meetings with representatives of other 
        foreign governments to discuss and reach agreement on methods 
        and approaches to harmonize regulatory requirements; and
            (3) the Office of International Relations of the Department 
        of Health and Human Services (as established under section 803 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383)) 
        should have the responsibility of ensuring that the process of 
        harmonizing international regulatory requirements is 
        continuous.

SEC. 203. CONTRACTS FOR EXPERT REVIEW.

    Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end 
the following:

``SEC. 906. CONTRACTS FOR EXPERT REVIEW.

    ``(a) In General.--
            ``(1) Authority.--The Secretary may enter into a contract 
        with any organization or any individual (who is not an employee 
        of the Department) with expertise in a relevant discipline, to 
        review, evaluate, and make recommendations to the Secretary on 
        part or all of any application or submission (including a 
        petition, notification, and any other similar form of request) 
        made under this Act for the approval or classification of an 
        article or made under section 351(a) of the Public Health 
        Service Act (42 U.S.C. 262(a)) with respect to a biological 
        product. Any such contract shall be subject to the requirements 
        of section 708 relating to the confidentiality of information.
            ``(2) Increased efficiency and expertise through 
        contracts.--The Secretary shall use the authority granted in 
        paragraph (1) whenever the Secretary determines that a contract 
        described in paragraph (1) will improve the timeliness or 
        quality of the review of an application or submission described 
        in paragraph (1). Such improvement may include providing the 
        Secretary increased scientific or technical expertise that is 
        necessary to review or evaluate new therapies and technologies.
    ``(b) Review of Expert Review.--
            ``(1) In general.--Subject to paragraph (2), the official 
        of the Food and Drug Administration responsible for any matter 
        for which expert review is used pursuant to subsection (a) 
        shall review the recommendations of the organization or 
        individual who conducted the expert review and shall make a 
        final decision regarding the matter within 60 days after 
        receiving the recommendations.
            ``(2) Limitation.--A final decision under paragraph (1) 
        shall be made within the applicable prescribed time period for 
        review of the matter as set forth in this Act or in the Public 
        Health Service Act (42 U.S.C. 201 et seq.).
            ``(3) Authority of secretary.--Notwithstanding subsection 
        (a), the Secretary shall retain full authority to make 
        determinations with respect to the approval or disapproval of 
        an article under this Act, the approval or disapproval of a 
        biologics license with respect to a biological product under 
        section 351(a) of the Public Health Service Act, or the 
        classification of an article as a device under section 
        513(f)(1).''.

SEC. 204. ACCREDITED-PARTY REVIEWS.

    Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by 
adding at the end the following:

``SEC. 523. ACCREDITED-PARTY PARTICIPATION.

    ``(a) Accreditation.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall accredit 
        entities or individuals who are not employees of the Federal 
        Government, to review reports made to the Secretary under 
        section 510(k) for devices and make recommendations to the 
        Secretary regarding the initial classification of such devices 
        under section 513(f)(1), except that this paragraph shall not 
        apply to reports made to the Secretary under section 510(k) for 
        devices that are--
                    ``(A) life-supporting;
                    ``(B) life sustaining; or
                    ``(C) intended for implantation in the human body 
                for a period of over 1 year.
            ``(2) Special rule.--The Secretary shall have the 
        discretion to accredit entities or individuals who are not 
        employees of the Federal Government--
                    ``(A) to review reports made to the Secretary under 
                section 510(k) for devices described in subparagraphs 
                (A) through (C) of paragraph (1), and make 
                recommendations of initial classification of such 
                devices; or
                    ``(B) to review applications for premarket approval 
                for class III devices under section 515 and make 
                recommendations with respect to the approval or 
                disapproval of such applications.
    ``(b) Accreditation.--Within 180 days after the date of enactment 
of this section, the Secretary shall adopt methods of accreditation 
that ensure that entities or individuals who conduct reviews and make 
recommendations under this section are qualified, properly trained, 
knowledgeable about handling confidential documents and information, 
and free of conflicts of interest. The Secretary shall publish the 
methods of accreditation in the Federal Register on the adoption of the 
methods.
    ``(c) Withdrawal of Accreditation.--The Secretary may suspend or 
withdraw the accreditation of any entity or individual accredited under 
this section, after providing notice and an opportunity for an informal 
hearing, if such entity or individual acts in a manner that is 
substantially not in compliance with the requirements established by 
the Secretary under subsection (b), including the failure to avoid 
conflicts of interest, the failure to protect confidentiality of 
information, or the failure to competently review premarket submissions 
for devices.
    ``(d) Selection and Compensation.--Subject to subsection (a)(2), a 
person who intends to make a report described in subsection (a), or to 
submit an application described in subsection (a), to the Secretary 
shall have the option to select an accredited entity or individual to 
review such report or application. Upon the request by a person to have 
a report or application reviewed by an accredited entity or individual, 
the Secretary shall identify for the person no less than 2 accredited 
entities or individuals from whom the selection may be made. 
Compensation for an accredited entity or individual shall be determined 
by agreement between the accredited entity or individual and the person 
who engages the services of the accredited entity or individual and 
shall be paid by the person who engages such services.
    ``(e) Review by Secretary.--
            ``(1) In general.--The Secretary shall require an 
        accredited entity or individual, upon making a recommendation 
        under this section with respect to an initial classification of 
        a device or approval or disapproval of an application for 
        premarket approval, to notify the Secretary in writing of the 
        reasons for such recommendation.
            ``(2) Time period for review.--
                    ``(A) Initial classification.--Not later than 30 
                days after the date on which the Secretary is notified 
                under paragraph (1) by an accredited entity or 
                individual with respect to a recommendation of an 
                initial classification of a device, the Secretary shall 
                make a determination with respect to the initial 
                classification.
                    ``(B) Premarket approval.--Not later than 60 days 
                after the date on which the Secretary is notified under 
                paragraph (1) by an accredited entity or individual 
                with respect to a recommendation of an approval or 
                disapproval of an application for a device, the 
                Secretary shall make a determination with respect to 
                the approval or disapproval.
            ``(3) Special rule.--The Secretary may change the initial 
        classification under section 513(f)(1), or the approval or 
        disapproval of the application under section 515(d), that is 
        recommended by the accredited entity or individual under this 
        section, and in such case shall notify in writing the person 
        making the report or application described in subsection (a) of 
        the detailed reasons for the change.
    ``(f) Duration.--The authority provided by this section 
terminates--
            ``(1) 5 years after the date on which the Secretary 
        notifies Congress that at least 2 persons accredited under 
        subsection (b) are available to review devices for each of at 
        least 70 percent of the generic types of devices subject to 
        review under subsection (a); or
            ``(2) 4 years after the date on which the Secretary 
        notifies Congress that at least 35 percent of the devices that 
        are subject to review under subsection (a), and that were the 
        subject of final action by the Secretary in the fiscal year 
        preceding the date of such notification, were reviewed by the 
        Secretary under subsection (e),
whichever occurs first.
    ``(g) Report.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall contract with an 
        independent research organization to prepare and submit to the 
        Secretary a written report examining the use of accredited 
        entities and individuals to conduct reviews under this section. 
        The Secretary shall submit the report to Congress not later 
        than 6 months prior to the conclusion of the applicable period 
        described in subsection (f).
            ``(2) Contents.--The report by the independent research 
        organization described in paragraph (1) shall identify the 
        benefits or detriments to public and patient health of using 
        accredited entities and individuals to conduct such reviews, 
        and shall summarize all relevant data, including data on the 
        review of accredited entities and individuals (including data 
        on the review times, recommendations, and compensation of the 
        entities and individuals), and data on the review of the 
        Secretary (including data on the review times, changes, and 
        reasons for changes of the Secretary).''.

SEC. 205. DEVICE PERFORMANCE STANDARDS.

    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended 
by adding at the end the following:

                      ``Recognition of a Standard

    ``(c)(1)(A) In addition to establishing performance standards under 
this section, the Secretary may, by publication in the Federal 
Register, recognize all or part of a performance standard established 
by a nationally or internationally recognized standard development 
organization for which a person may submit a declaration of conformity 
in order to meet premarket submission requirements or other 
requirements under this Act to which such standards are applicable.
    ``(B) If a person elects to use a performance standard recognized 
by the Secretary under subparagraph (A) to meet the requirements 
described in subparagraph (A), the person shall provide a declaration 
of conformity to the Secretary that certifies that the device is in 
conformity with such standard. A person may elect to use data, or 
information, other than data required by a standard recognized under 
subparagraph (A) to fulfill or satisfy any requirement under this Act.
    ``(2) The Secretary may withdraw such recognition of a performance 
standard through publication of a notice in the Federal Register that 
the Secretary will no longer recognize the standard, if the Secretary 
determines that the standard is no longer appropriate for meeting the 
requirements under this Act.
    ``(3)(A) Subject to subparagraph (B), the Secretary shall accept a 
declaration of conformity that a device is in conformity with a 
standard recognized under paragraph (1) unless the Secretary finds--
            ``(i) that the data or information submitted to support 
        such declaration does not demonstrate that the device is in 
        conformity with the standard identified in the declaration of 
        conformity; or
            ``(ii) that the standard identified in the declaration of 
        conformity is not applicable to the particular device under 
        review.
    ``(B) The Secretary may request, at any time, the data or 
information relied on by the person to make a declaration of conformity 
with respect to a standard recognized under paragraph (1).
    ``(C) A person relying on a declaration of conformity with respect 
to a standard recognized under paragraph (1) shall maintain the data 
and information demonstrating conformity of the device to the standard 
for a period of 2 years after the date of the classification or 
approval of the device by the Secretary or a period equal to the 
expected design life of the device, whichever is longer.''.
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(x) The falsification of a declaration of conformity submitted 
under subsection (c) of section 514 or the failure or refusal to 
provide data or information requested by the Secretary under section 
514(c)(3).''.
    (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended--
            (1) by striking ``(e)'' and inserting ``(e)(1)''; and
            (2) by inserting at the end the following:
    ``(2) If it is, declared to be, purports to be, or is represented 
as, a device that is in conformity with any performance standard 
recognized under section 514(c) unless such device is in all respects 
in conformity with such standard.''.

          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS.

    Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at 
the end the following:
    ``(C)(i)(I) The Secretary, upon the written request of any person 
intending to submit an application under section 515, shall meet with 
such person to determine the type of valid scientific evidence (within 
the meaning of subparagraphs (A) and (B)) that will be necessary to 
demonstrate the effectiveness of a device for the conditions of use 
proposed by such person, to support an approval of an application. The 
written request shall include a detailed description of the device, a 
detailed description of the proposed conditions of use of the device, 
and, if available, information regarding the expected performance from 
the device. Within 30 days after such meeting, the Secretary shall 
specify in writing the type of valid scientific evidence that will 
provide a reasonable assurance that a device is effective under the 
conditions of use proposed by such person.
    ``(II) Any clinical data, including 1 or more well-controlled 
investigations, specified in writing by the Secretary for demonstrating 
a reasonable assurance of device effectiveness shall be specified as a 
result of a determination by the Secretary--
            ``(aa) that such data are necessary to establish device 
        effectiveness; and
            ``(bb) that no other less burdensome means of evaluating 
        device effectiveness is available that would have a reasonable 
        likelihood of resulting in an approval.
    ``(ii) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clause (i) shall be 
binding upon the Secretary, unless--
            ``(I) such determination by the Secretary would be contrary 
        to the public health; or
            ``(II) based on new information (other than the information 
        reviewed by the Secretary in making such determination) 
        obtained by the Secretary prior to the approval of an 
        application for an investigational device exemption under 
        section 520(g), the Secretary finds that such determination is 
        scientifically inappropriate.''.

SEC. 302. COLLABORATIVE REVIEW PROCESS.

    Section 515(d) (21 U.S.C. 360e(d)) is amended--
            (1) in paragraph (1)(A), by striking ``paragraph (2) of 
        this subsection'' each place it appears and inserting 
        ``paragraph (4)'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (4) and (5), respectively; and
            (3) by inserting after paragraph (1) the following:
    ``(2)(A)(i) The Secretary shall, upon the written request of the 
applicant involved, meet with the applicant not later than 100 days 
after the receipt of an application, from the applicant, that has been 
filed as complete under subsection (c), to discuss the review status of 
the application.
    ``(ii) If the application does not appear in a form that would 
require an approval under this subsection, the Secretary shall in 
writing, and prior to the meeting, provide to the applicant a 
description of any deficiencies in the application identified by the 
Secretary and identify the information (other than information the 
Secretary needs to make a finding under paragraph (4)(C)) that is 
required to bring the application into an approvable form.
    ``(iii) The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under this 
paragraph.
    ``(B) The Secretary shall notify the applicant immediately of any 
deficiency identified in the application that was not described as a 
deficiency in the written description provided by the Secretary under 
subparagraph (A).''.

           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

SEC. 401. POLICY STATEMENTS.

    Section 701(a) (21 U.S.C. 371(a)) is amended--
            (1) by striking ``(a) The'' and inserting ``(a)(1) The''; 
        and
            (2) by adding at the end the following:
    ``(2) Not later than February 27, 1999, the Secretary, after 
evaluating the effectiveness of the Good Guidance Practices document 
published in the Federal Register at 62 Fed. Reg. 8961, shall 
promulgate a regulation specifying the policies and procedures of the 
Food and Drug Administration for the development, issuance, and use of 
guidance documents.''.

SEC. 402. PRODUCT CLASSIFICATION.

    Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end 
the following:

  ``Subchapter D--Classification of Products and Environmental Impact 
                                Reviews

``SEC. 741. CLASSIFICATION OF PRODUCTS.

    ``(a) Request.--A person who submits an application or submission 
(including a petition, notification, and any other similar form of 
request) under this Act, may submit a request to the Secretary 
respecting the classification of an article (including an article that 
is a combination product subject to section 503(g)) as a drug, 
biological product, or device, or respecting the component of the Food 
and Drug Administration that will regulate the article. In submitting 
the request, the person shall recommend a classification for the 
article, or a component to regulate the article, as appropriate.
    ``(b) Statement.--Not later than 60 days after the receipt of the 
request described in subsection (a), the Secretary shall determine the 
classification of the article or the component of the Food and Drug 
Administration that will regulate the article and shall provide to the 
person a written statement that identifies the classification of the 
article or the component of the Food and Drug Administration that will 
regulate the article and the reasons for such determination. The 
Secretary may not modify such statement except with the written consent 
of the person or for public health reasons.
    ``(c) Inaction of Secretary.--If the Secretary does not provide the 
statement within the 60-day period described in subsection (b), the 
recommendation made by the person under subsection (a) shall be 
considered to be a final determination by the Secretary of the 
classification of the article or the component of the Food and Drug 
Administration that will regulate the article and may not be modified 
by the Secretary except with the written consent of the person or for 
public health reasons.''.

SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL.

    (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is 
amended to read as follows:
    ``(4)(A) Any information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) (including 
information from clinical and preclinical tests or studies that 
demonstrate the safety and effectiveness of a device, but excluding 
descriptions of methods of manufacture and product composition) shall 
be available, 6 years after the application has been approved by the 
Secretary, for use by the Secretary in--
            ``(i) approving another device;
            ``(ii) determining whether a product development protocol 
        has been completed, under section 515 for another device;
            ``(iii) establishing a performance standard or special 
        control under this Act; or
            ``(iv) classifying or reclassifying another device under 
        section 513 and subsection (l)(2).
    ``(B) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by 
paragraph (1)(A) shall be available for use by the Secretary as the 
evidentiary basis for the agency action described in subparagraph 
(A).''.
    (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 360g(a)) is 
amended--
            (1) in paragraph (8), by adding ``or'' at the end;
            (2) in paragraph (9), by striking ``, or'' and inserting a 
        comma; and
            (3) by striking paragraph (10).

SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT REVIEW.

    (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 
360e(d)(1)(A)) is amended by adding at the end the following flush 
sentences:
``In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use included 
in the proposed labeling as the basis for determining whether or not 
there is a reasonable assurance of safety and effectiveness, if the 
proposed labeling is neither false nor misleading. In determining 
whether or not such labeling is false or misleading, the Secretary 
shall fairly evaluate all material facts pertinent to the proposed 
labeling.''.
    (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 
360c(i)(1)) is amended by adding at the end the following:
    ``(C) Whenever the Secretary requests information to demonstrate 
that the devices with differing technological characteristics are 
substantially equivalent, the Secretary shall only request information 
that is necessary to make a substantial equivalence determination. In 
making such a request, the Secretary shall consider the least 
burdensome means of demonstrating substantial equivalence and shall 
request information accordingly.
    ``(D) The determinations of the Secretary under this section and 
section 513(f)(1) with respect to the intended use of a device shall be 
based on the intended use included in proposed labeling of the device 
submitted in a report under section 510(k).''.

SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW.

    Section 201 (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ii) In any provision relating to a review of any application or 
submission (including a petition, notification, and any other similar 
form of request), made under this Act with respect to an article that 
is a new drug, device, biological product, new animal drug, an animal 
feed bearing or containing a new animal drug, color additive, or food 
additive, that is submitted to the Secretary to obtain marketing 
approval, to obtain classification of a device under section 513(f)(1), 
or to establish or clarify the regulatory status of the article--
            ``(1) the term `day' means a calendar day in which the 
        Secretary has responsibility to review such an application or 
        submission; and
            ``(2) a reference to a date relating to the receipt of such 
        an application or submission by the Secretary shall be deemed 
        to be a reference to the date on which the Secretary receives a 
        complete application or submission within the meaning of this 
        Act and the regulations promulgated under this Act.''.

SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES.

    (a) Clarification on the 90-Day Timeframe for Premarket 
Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by 
adding at the end the following flush sentence:
``The Secretary shall review the notification required by this 
subsection and make a determination under section 513(f)(1) not later 
than 90 days after receiving the notification.''.
    (b) Certainty of 180-Day Review Timeframe.--Section 515(d) (21 
U.S.C. 360e(d)), as amended by section 302, is amended by inserting 
after paragraph (2) the following:
    ``(3) Except as provided in paragraph (1), the period for the 
review of an application by the Secretary under this subsection shall 
be not more than 180 days. Such period may not be restarted or extended 
even if the application is amended.''.

SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION DETERMINATIONS.

    Section 510 (21 U.S.C. 360) is amended by adding at the end the 
following:
    ``(m) The Secretary may not withhold a determination of the initial 
classification of a device under section 513(f)(1) because of a failure 
to comply with any provision of this Act that is unrelated to a 
substantial equivalence decision, including a failure to comply with 
the requirements relating to good manufacturing practices under section 
520(f).''.

SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND SPECIFIC USE 
              OF A DEVICE.

    Not later than 270 days after the date of enactment of this 
section, the Secretary of Health and Human Services shall promulgate a 
final regulation specifying the general principles that the Secretary 
of Health and Human Services will consider in determining when a 
specific intended use of a device is not reasonably included within a 
general use of such device for purposes of a determination of 
substantial equivalence under section 513(f)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).

SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
              INVESTIGATIONS FOR APPROVAL.

    (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) 
is amended by striking ``clinical investigations'' and inserting ``1 or 
more clinical investigations''.
    (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is amended by 
adding at the end the following: ``Substantial evidence may, as 
appropriate, consist of data from 1 adequate and well-controlled 
clinical investigation and confirmatory evidence (obtained prior to or 
after such investigation), if the Secretary determines, based on 
relevant science, that such data and evidence are sufficient to 
establish effectiveness.''.

SEC. 410. PROHIBITED ACTS.

    Section 301(l) (21 U.S.C. 331(l)) is repealed.

                   TITLE V--IMPROVING ACCOUNTABILITY

SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL REPORT.

    Section 903(b) (21 U.S.C. 393(b)), as amended by section 201, is 
further amended by adding at the end the following:
            ``(4) Agency plan for statutory compliance.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of this paragraph, the Secretary, 
                after consultation with relevant experts, health care 
                professionals, representatives of patient and consumer 
                advocacy groups, and the regulated industry, shall 
                develop and publish in the Federal Register a plan 
                bringing the Secretary into compliance with each of the 
                obligations of the Secretary under this Act and other 
                relevant statutes. The Secretary shall biannually 
                review the plan and shall revise the plan as necessary, 
                in consultation with such persons.
                    ``(B) Objectives of agency plan.--The plan required 
                by subparagraph (A) shall establish objectives, and 
                mechanisms to be used by the Secretary, acting through 
                the Commissioner, including objectives and mechanisms 
                that--
                            ``(i) minimize deaths of, and harm to, 
                        persons who use or may use an article regulated 
                        under this Act;
                            ``(ii) maximize the clarity of, and the 
                        availability of information about, the process 
                        for review of applications and submissions 
                        (including petitions, notifications, and any 
                        other similar forms of request) made under this 
                        Act, including information for potential 
                        consumers and patients concerning new products;
                            ``(iii) implement all inspection and 
                        postmarket monitoring provisions of this Act by 
                        July 1, 1999;
                            ``(iv) ensure access to the scientific and 
                        technical expertise necessary to ensure 
                        compliance by the Secretary with the statutory 
                        obligations described in subparagraph (A);
                            ``(v) establish a schedule to bring the 
                        Administration into full compliance by July 1, 
                        1999, with the time periods specified in this 
                        Act for the review of all applications and 
                        submissions described in clause (ii) and 
                        submitted after the date of enactment of this 
                        paragraph; and
                            ``(vi) reduce backlogs in the review of all 
                        applications and submissions described in 
                        clause (ii) for any article with the objective 
                        of eliminating all backlogs in the review of 
                        the applications and submissions by January 1, 
                        2000.
            ``(5) Annual report.--
                    ``(A) Contents.--The Secretary shall prepare and 
                publish in the Federal Register and solicit public 
                comment on an annual report that--
                            ``(i) provides detailed statistical 
                        information on the performance of the Secretary 
                        under the plan described in paragraph (4);
                            ``(ii) compares such performance of the 
                        Secretary with the objectives of the plan and 
                        with the statutory obligations of the 
                        Secretary;
                            ``(iii) analyzes any failure of the 
                        Secretary to achieve any objective of the plan 
                        or to meet any statutory obligation;
                            ``(iv) identifies any regulatory policy 
                        that has a significant impact on compliance 
                        with any objective of the plan or any statutory 
                        obligation; and
                            ``(v) sets forth any proposed revision to 
                        any such regulatory policy, or objective of the 
                        plan that has not been met.
                    ``(B) Statistical information.--The statistical 
                information described in subparagraph (A)(i) shall 
                include a full statistical presentation relating to all 
                applications and submissions (including petitions, 
                notifications, and any other similar forms of request) 
                made under this Act and approved or subject to final 
                action by the Secretary during the year covered by the 
                report. In preparing the statistical presentation, the 
                Secretary shall take into account the date of--
                            ``(i) the submission of any investigational 
                        application;
                            ``(ii) the application of any clinical 
                        hold;
                            ``(iii) the submission of any application 
                        or submission (including a petition, 
                        notification, and any other similar form of 
                        request) made under this Act for approval or 
                        clearance;
                            ``(iv) the acceptance for filing of any 
                        application or submission described in clause 
                        (iii) for approval or clearance;
                            ``(v) the occurrence of any unapprovable 
                        action;
                            ``(vi) the occurrence of any approvable 
                        action; and
                            ``(vii) the approval or clearance of any 
                        application or submission described in clause 
                        (iii).''.

     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

SEC. 601. MINOR MODIFICATIONS.

    (a) Action on Investigational Device Exemptions.--Section 520(g) 
(21 U.S.C. 360j(g)) is amended by adding at the end the following:
    ``(6)(A) The Secretary shall, not later than 120 days after the 
date of enactment of this paragraph, by regulation modify parts 812 and 
813 of title 21, Code of Federal Regulations to update the procedures 
and conditions under which a device intended for human use may, upon 
application by the sponsor of the device, be granted an exemption from 
the requirements of this Act.
    ``(B) The regulation shall permit developmental changes in a device 
(including manufacturing changes) in response to information collected 
during an investigation without requiring an additional approval of an 
application for an investigational device exemption or the approval of 
a supplement to such application, if the sponsor of the investigation 
determines, based on credible information, prior to making any such 
changes, that the changes--
            ``(i) do not affect the scientific soundness of an 
        investigational plan submitted under paragraph (3)(A) or the 
        rights, safety, or welfare of the human subjects involved in 
        the investigation; and
            ``(ii) do not constitute a significant change in design, or 
        a significant change in basic principles of operation, of the 
        device.''.
    (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 
360e(d)(1)(B)) is amended by adding at the end the following:
    ``(iii) The Secretary shall accept and review data and any other 
information from investigations conducted under the authority of 
regulations required by section 520(g), to make a determination of 
whether there is a reasonable assurance of safety and effectiveness of 
a device subject to a pending application under this section if--
            ``(I) the data or information is derived from 
        investigations of an earlier version of the device, the device 
        has been modified during or after the investigations (but prior 
        to submission of an application under subsection (c)) and such 
        a modification of the device does not constitute a significant 
        change in the design or in the basic principles of operation of 
        the device that would invalidate the data or information; or
            ``(II) the data or information relates to a device approved 
        under this section, is available for use under this Act, and is 
        relevant to the design and intended use of the device for which 
        the application is pending.''.
    (c) Action on Supplements.--Section 515(d) (21 U.S.C. 360e(d)), as 
amended by section 302, is further amended by adding at the end the 
following:
    ``(6)(A)(i) A supplemental application shall be required for any 
change to a device subject to an approved application under this 
subsection that affects safety or effectiveness, unless such change is 
a modification in a manufacturing procedure or method of manufacturing 
and the holder of the approved application submits a written notice to 
the Secretary that describes in detail the change, summarizes the data 
or information supporting the change, and informs the Secretary that 
the change has been made under the requirements of section 520(f).
    ``(ii) The holder of an approved application who submits a notice 
under clause (i) with respect to a manufacturing change of a device 
shall not distribute the device for a period of 14 days after the date 
on which the Secretary receives the notice.
    ``(B)(i) Subject to clause (ii), in reviewing a supplement to an 
approved application, for an incremental change to the design of a 
device that affects safety or effectiveness, the Secretary shall 
approve such supplement if--
            ``(I) nonclinical data demonstrate that the design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and
            ``(II) clinical data from the approved application and any 
        supplement to the approved application provide a reasonable 
        assurance of safety and effectiveness for the changed device.
    ``(ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification to provide a 
reasonable assurance of safety and effectiveness.''.

SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is 
further amended by adding at the end the following:

``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

    ``Notwithstanding any other provision of law, no action by the 
Secretary pursuant to this Act shall be subject to an environmental 
assessment, an environmental impact statement, or other environmental 
consideration unless the Secretary demonstrates, in writing--
            ``(1) that there is a reasonable probability that the 
        environmental impact of the action is sufficiently substantial 
        and within the factors that the Secretary is authorized to 
        consider under this Act; and
            ``(2) that consideration of the environmental impact will 
        directly affect the decision on the action.''.

SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM PREMARKET 
              NOTIFICATION REQUIREMENT.

    (a) Class I and Class II Devices.--Section 510(k) (21 U.S.C. 
360(k)) is amended by striking ``intended for human use'' and inserting 
``intended for human use (except a device that is classified into class 
I under section 513 or 520 unless the Secretary determines such device 
is intended for a use that is of substantial importance in preventing 
impairment of human health or such device presents a potential 
unreasonable risk of illness or injury, or a device that is classified 
into class II under section 513 or 520 and is exempt from the 
requirements of this subsection under subsection (l))''.
    (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) is 
amended by inserting after subsection (k) the following:
    ``(l)(1) Not later than 30 days after the date of enactment of this 
subsection, the Secretary shall publish in the Federal Register a list 
of each type of class II device that does not require a notification 
under subsection (k) to provide reasonable assurance of safety and 
effectiveness. Each type of class II device identified by the Secretary 
not to require the notification shall be exempt from the requirement to 
provide notification under subsection (k) as of the date of the 
publication of the list in the Federal Register.
    ``(2) Beginning on the date that is 1 day after the date of the 
publication of a list under this subsection, the Secretary may exempt a 
class II device from the notification requirement of subsection (k), 
upon the Secretary's own initiative or a petition of an interested 
person, if the Secretary determines that such notification is not 
necessary to assure the safety and effectiveness of the device. The 
Secretary shall publish in the Federal Register notice of the intent of 
the Secretary to exempt the device, or of the petition, and provide a 
30-day comment period for public comment. Within 120 days after the 
issuance of the notice in the Federal Register, the Secretary shall 
publish an order in the Federal Register that sets forth the final 
determination of the Secretary regarding the exemption of the device 
that was the subject of the notice.''.

SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

    Section 513(f) (21 U.S.C. 360c(f)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (B), by striking ``paragraph 
                (2)'' and inserting ``paragraph (3)''; and
                    (B) in the last sentence, by striking ``paragraph 
                (2)'' and inserting ``paragraph (2) or (3)'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively; and
            (3) by inserting after paragraph (1) the following:
    ``(2)(A) Any person who submits a report under section 510(k) for a 
type of device that has not been previously classified under this Act, 
and that is classified into class III under paragraph (1), may request, 
within 30 days after receiving written notice of such a classification, 
the Secretary to classify the device into class I or II under the 
criteria set forth in subparagraphs (A) through (C) subsection (a)(1). 
The person may, in the request, recommend to the Secretary a 
classification for the device. The request shall describe the device 
and provide detailed information and reasons for the recommended 
classification.
    ``(B)(i) Not later than 60 days after the date of the submission of 
the request under subparagraph (A) for classification of a device under 
the criteria set forth in subparagraphs (A) through (C) of subsection 
(a)(1), the Secretary shall by written order classify the device. Such 
classification shall be the initial classification of the device for 
purposes of paragraph (1) and any device classified under this 
paragraph into class I or II shall be a predicate device for 
determining substantial equivalence under paragraph (1).
    ``(ii) A device that remains in class III under this subparagraph 
shall be deemed to be adulterated within the meaning of section 
501(f)(1)(B) until approved under section 515 or exempted from such 
approval under section 520(g).
    ``(C) Within 30 days after the issuance of an order classifying a 
device under this paragraph, the Secretary shall publish a notice in 
the Federal Register announcing such classification.''.

SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES.

    (a) Release of Information.--Section 519(e) (21 U.S.C. 360i(e)) is 
amended by adding at the end the following flush sentence:
``Any patient receiving a device subject to tracking under this section 
may refuse to release, or refuse permission to release, the patient's 
name, address, social security number, or other identifying information 
for the purpose of tracking.''.
    (b) Publication of Certain Devices.--Not later than 180 days after 
the date of enactment of this Act, the Secretary of Health and Human 
Services shall develop and publish in the Federal Register a list that 
identifies each type of device subject to tracking under section 
519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360i(e)(1)). Each device not identified by the Secretary of Health and 
Human Services under this subsection or designated by the Secretary 
under section 519(e)(2) shall be deemed to be exempt from the mandatory 
tracking requirement under section 519 of such Act. The Secretary of 
Health and Human Services shall have authority to modify the list of 
devices exempted from the mandatory tracking requirements.

SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET SURVEILLANCE.

    (a) In General.--Section 522 (21 U.S.C. 360l) is amended by 
striking ``Sec. 522.'' and all that follows through ``(2) Discretionary 
surveillance.--The'' and inserting the following:
    ``Sec. 522. (a) Discretionary Surveillance.--The''.
    (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 360l(b)) is 
amended to read as follows:
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each manufacturer that receives notice 
        from the Secretary that the manufacturer is required to conduct 
        surveillance of a device under subsection (a) shall, not later 
        than 30 days after receiving the notice, submit for the 
        approval of the Secretary, a plan for the required 
        surveillance.
            ``(2) Determination.--Not later than 60 days after the 
        receipt of the plan, the Secretary shall determine if a person 
        proposed in the plan to conduct the surveillance has sufficient 
        qualifications and experience to conduct the surveillance and 
        if the plan will result in the collection of useful data that 
        can reveal unforeseen adverse events or other information 
        necessary to protect the public health and to provide safety 
        and effectiveness information for the device.
            ``(3) Limitation on plan approval.--The Secretary may not 
        approve the plan until the plan has been reviewed by a 
        qualified scientific and technical review committee established 
        by the Secretary.''.
    (c) Duration of Surveillance.--Section 522 (21 U.S.C. 360l), as 
amended by subsection (b), is further amended by adding at the end the 
following:
    ``(c) Duration of Surveillance.--
            ``(1) In general.--Each manufacturer required to conduct 
        surveillance of a device under subsection (a) shall be required 
        to conduct such surveillance for not longer than 24 months.
            ``(2) Extension of the period of surveillance.--If the 
        Secretary determines that additional surveillance is needed to 
        identify the incidence of adverse events documented during the 
        initial period of surveillance that were not foreseen at the 
        time of approval or classification of the device, the Secretary 
        may extend the period of surveillance for such time as may be 
        necessary after providing the person required to conduct such 
        surveillance an opportunity for an informal hearing to 
        determine whether or not additional surveillance is appropriate 
        and to determine the appropriate period, if any, for such 
        surveillance.''.

SEC. 607. REPORTING.

    (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
            (1) in subsection (a)--
                    (A) in the first sentence by striking ``make such 
                reports, and provide such information,'' and inserting 
                ``and submit such samples and components of devices (as 
                required by paragraph (10)),''; and
                    (B) by inserting after the first sentence the 
                following: ``Every person who is a manufacturer or 
                importer of a device intended for human use shall make 
                reports, and provide such information, as the Secretary 
                may by regulation reasonably require to assure that 
                such device is not adulterated or misbranded and to 
                assure the safety and effectiveness of such device.'';
                    (C) in the last sentence by striking ``sentence'' 
                and inserting ``sentences'';
                    (D) in paragraph (8), by striking ``; and'' and 
                inserting a semicolon; and
                    (E) by striking paragraph (9) and inserting the 
                following:
            ``(9) shall require distributors to keep records and make 
        such records available to the Secretary upon request; and'';
            (2) by striking subsection (d); and
            (3) in subsection (f), by striking ``, importer, or 
        distributor'' each place it appears and inserting ``or 
        importer''.
    (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended--
            (1) by redesignating paragraph (4) as paragraph (5);
            (2) by inserting after paragraph (3), the following:
            ``(4) any distributor who acts as a wholesale distributor 
        of devices, and who does not manufacture, repackage, process, 
        or relabel a device; or''; and
            (3) by adding at the end the following flush sentence:
``In this subsection, the term `wholesale distributor' means any person 
who distributes a device from the original place of manufacture to the 
person who makes the final delivery or sale of the device to the 
ultimate consumer or user.''.

SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE.

    Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end 
the following:
    ``(4) A new drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the new drug 
and to obtain approval of the new drug prior to scaling up to a larger 
facility, unless the Secretary determines that a full scale production 
facility is necessary to ensure the safety or effectiveness of the new 
drug.''.

SEC. 609. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

    (a) Requirements.--
            (1) Regulations.--
                    (A) Proposed regulations.--Not later than 180 days 
                after the date of enactment of this Act, the Secretary 
                of Health and Human Services, after consultation with 
                patient advocacy groups, associations, physicians 
                licensed to use radiopharmaceuticals, and the regulated 
                industry, shall issue proposed regulations governing 
                the approval of radiopharmaceuticals designed for 
                diagnosis and monitoring of diseases and conditions. 
                The regulations shall provide that the determination of 
                the safety and effectiveness of such a 
                radiopharmaceutical under section 505 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 
                351 of the Public Health Service Act (42 U.S.C. 262) 
                shall include (but not be limited to) consideration of 
                the proposed use of the radiopharmaceutical in the 
                practice of medicine, the pharmacological and 
                toxicological activity of the radiopharmaceutical 
                (including any carrier or ligand component of the 
                radiopharmaceutical), and the estimated absorbed 
                radiation dose of the radiopharmaceutical.
                    (B) Final regulations.--Not later than 18 months 
                after the date of enactment of this Act, the Secretary 
                shall promulgate final regulations governing the 
                approval of the radiopharmaceuticals.
            (2) Special rule.--In the case of a radiopharmaceutical 
        intended to be used for diagnostic or monitoring purposes, the 
        indications for which such radiopharmaceutical is approved for 
        marketing may, in appropriate cases, refer to manifestations of 
        disease (such as biochemical, physiological, anatomic, or 
        pathological processes) common to, or present in, 1 or more 
        disease states.
    (b) Definition.--In this section, the term ``radiopharmaceutical'' 
means--
            (1) an article--
                    (A) that is intended for use in the diagnosis or 
                monitoring of a disease or a manifestation of a disease 
                in humans; and
                    (B) that exhibits spontaneous disintegration of 
                unstable nuclei with the emission of nuclear particles 
                or photons; or
            (2) any nonradioactive reagent kit or nuclide generator 
        that is intended to be used in the preparation of any such 
        article.

SEC. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.

    (a) Licenses.--
            (1) In general.--Section 351(a) of the Public Health 
        Service (42 U.S.C. 262(a)) is amended to read as follows:
    ``(a)(1) Except as provided in paragraph (4), no person shall 
introduce or deliver for introduction into interstate commerce any 
biological product unless--
            ``(A) a biologics license is in effect for the biological 
        product; and
            ``(B) each package of the biological product is plainly 
        marked with--
                    ``(i) the proper name of the biological product 
                contained in the package;
                    ``(ii) the name, address, and applicable license 
                number of the manufacturer of the biological product; 
                and
                    ``(iii) the expiration date of the biological 
                product.
    ``(2)(A) The Secretary shall establish, by regulation, requirements 
for the approval, suspension, and revocation of biologics licenses.
    ``(B) The Secretary shall approve a biologics license application 
on the basis of a demonstration that--
            ``(i) the biological product that is the subject of the 
        application is safe, pure, and potent; and
            ``(ii) the facility in which the biological product is 
        manufactured, processed, packed, or held meets standards 
        designed to assure that the biological product continues to be 
        safe, pure, and potent.
    ``(3) A biologics license application shall be approved only if the 
applicant (or other appropriate person) consents to the inspection of 
the facility that is the subject of the application, in accordance with 
subsection (c).
    ``(4) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt from the 
requirements of paragraph (1).''.
            (2) Elimination of existing license requirement.--Section 
        351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
        amended--
                    (A) by striking ``(d)(1)'' and all that follows 
                through ``of this section.'';
                    (B) in paragraph (2)--
                            (i) by striking ``(2)(A) Upon'' and 
                        inserting ``(d)(1) Upon;'' and
                            (ii) by redesignating subparagraph (B) as 
                        paragraph (2); and
                    (C) in paragraph (2) (as so redesignated by 
                subparagraph (B)(ii))--
                            (i) by striking ``subparagraph (A)'' and 
                        inserting ``paragraph (1)''; and
                            (ii) by striking ``this subparagraph'' each 
                        place it appears and inserting ``this 
                        paragraph''.
    (b) Labeling.--Section 351(b) of the Public Health Service Act (42 
U.S.C. 262(b)) is amended to read as follows:
    ``(b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark on the 
package or container of the biological product so as to falsify the 
label or mark.''.
    (c) Inspection.--Section 351(c) of the Public Health Service Act 
(42 U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all 
that follows and inserting ``biological product.''.
    (d) Definition; Application.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
    ``(i) In this section, the term `biological product' means a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or 
derivative, allergenic product, analogous product, or arsphenamine or 
derivative of arsphenamine (or any other trivalent organic arsenic 
compound), applicable to the prevention, treatment, or cure of a 
disease or condition of human beings.''.
    (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 353(g)(4)) 
is amended--
            (1) in subparagraph (A)--
                    (A) by striking ``section 351(a)'' and inserting 
                ``section 351(i)''; and
                    (B) by striking ``262(a)'' and inserting 
                ``262(i)''; and
            (2) in subparagraph (B)(iii), by striking ``product or 
        establishment license under subsection (a) or (d)'' and 
        inserting ``biologics license application under subsection 
        (a)''.
    (f) Special Rule.--The Secretary of Health and Human Services shall 
take measures to minimize differences in the review and approval of 
products required to have approved biologics license applications under 
section 351 of the Public Health Service Act (42 U.S.C. 262) and 
products required to have approved full new drug applications under 
section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)).

SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.

    (a) Performance Standards.--Not later than 180 days after the date 
of enactment of this section, the Secretary of Health and Human 
Services shall publish in the Federal Register performance standards 
for the prompt review of supplemental applications submitted for 
approved articles under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.).
    (b) Guidance to Industry.--Not later than 180 days after the date 
of enactment of this section, the Secretary of Health and Human 
Services shall issue final guidances to clarify the requirements for, 
and facilitate the submission of data to support, the approval of 
supplemental applications for the approved articles described in 
subsection (a). The guidances shall--
            (1) clarify circumstances in which published matter may be 
        the basis for approval of a supplemental application;
            (2) specify data requirements that will avoid duplication 
        of previously submitted data by recognizing the availability of 
        data previously submitted in support of an original 
        application; and
            (3) define supplemental applications that are eligible for 
        priority review.
    (c) Responsibilities of Centers.--The Secretary of Health and Human 
Services shall designate an individual in each center within the Food 
and Drug Administration (except the Center for Food Safety and Applied 
Nutrition) to be responsible for--
            (1) encouraging the prompt review of supplemental 
        applications for approved articles; and
            (2) working with sponsors to facilitate the development and 
        submission of data to support supplemental applications.
    (d) Collaboration.--The Secretary of Health and Human Services 
shall implement programs and policies that will foster collaboration 
between the Food and Drug Administration, the National Institutes of 
Health, professional medical and scientific societies, and other 
persons, to identify published and unpublished studies that may support 
a supplemental application, and to encourage sponsors to make 
supplemental applications or conduct further research in support of a 
supplemental application based, in whole or in part, on such studies.

SEC. 612. HEALTH CARE ECONOMIC INFORMATION.

    Section 502 (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(u) In the case of a health care economic statement that is 
included in labeling or advertising provided to a formulary committee, 
managed care organization, or similar entity with responsibility for 
drug selection decisions (other than the label or approved physician 
package insert) relating to an indication approved under section 505 or 
351 of the Public Health Service Act (42 U.S.C. 262), if the health 
care economic statement is not based on competent and reliable 
scientific evidence. The only requirements applicable to any such 
statement under this Act shall be the requirements of this paragraph. 
In this paragraph, the term `health care economic statement' means any 
statement that identifies, measures, or compares the costs (direct, 
indirect, and intangible) and health care consequences of a drug to 
another drug, to another health care intervention for the same 
indication, or to no intervention, where the primary endpoint is an 
economic outcome.''.

SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

    (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as amended by 
section 102, is further amended by adding at the end the following:

                    ``Subchapter E--Fast Track Drugs

``SEC. 561. FAST TRACK DRUGS.

    ``(a) Designation of Drug as a Fast Track Drug.--
            ``(1) In general.--The Secretary shall facilitate 
        development, and expedite review and approval of new drugs and 
        biological products that are intended for the treatment of 
        serious or life-threatening conditions and that demonstrate the 
        potential to address unmet medical needs for such conditions. 
        In this Act, such products shall be known as `fast track 
        drugs'.
            ``(2) Request for designation.--The sponsor of a drug 
        (including a biological product) may request the Secretary to 
        designate the drug as a fast track drug. A request for the 
        designation may be made concurrently with, or at any time 
        after, submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(4) of the 
        Public Health Service Act.
            ``(3) Designation.--Within 30 calendar days after the 
        receipt of a request under paragraph (2), the Secretary shall 
        determine whether the drug that is the subject of the request 
        meets the criteria described in paragraph (1). If the Secretary 
        finds that the drug meets the criteria, the Secretary shall 
        designate the drug as a fast track drug and shall take such 
        actions as are appropriate to expedite the development and 
        review of the drug.
    ``(b) Approval of Application for a Fast Track Drug.--
            ``(1) In general.--The Secretary may approve an application 
        for approval of a fast track drug under section 505(b) or 
        section 351 of the Public Health Service Act (21 U.S.C. 262) 
        upon a determination that the drug has an effect on a surrogate 
        endpoint that is reasonably likely to predict clinical benefit.
            ``(2) Limitation.--Approval of a fast track drug under this 
        subsection may be subject to the requirements--
                    ``(A) that the sponsor conduct appropriate post-
                approval studies to validate the surrogate endpoint or 
                otherwise confirm the clinical benefit of the drug; and
                    ``(B) that the sponsor submit copies of all 
                promotional materials related to the fast track drug 
                during the preapproval review period and following 
                approval, at least 30 days prior to dissemination of 
                the materials for such period of time as the Secretary 
                deems appropriate.
            ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a fast track drug using expedited 
        procedures (as prescribed by the Secretary in regulations) 
        including a procedure that provides an opportunity for an 
        informal hearing, if--
                    ``(A) the sponsor fails to conduct any required 
                post-approval study of the fast track drug with due 
                diligence;
                    ``(B) a post-approval study of the fast track drug 
                fails to verify clinical benefit of the fast track 
                drug;
                    ``(C) other evidence demonstrates that the fast 
                track drug is not safe or effective under conditions of 
                use of the drug; or
                    ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the fast track 
                drug.
    ``(c) Review of Incomplete Applications for Approval of a Fast 
Track Drug.--
            ``(1) In general.--If preliminary evaluation by the 
        Secretary of clinical efficacy data for a fast track drug under 
        investigation shows evidence of effectiveness, the Secretary 
        shall evaluate for filing, and may commence review of portions, 
        of an application for the approval of the drug if the applicant 
        provides a schedule for submission of information necessary to 
        make the application complete and any fee that may be required 
        under section 736.
            ``(2) Exception.--Any time period for review of human drug 
        applications that has been agreed to by the Secretary and that 
        has been set forth in goals identified in letters of the 
        Secretary (relating to the use of fees collected under section 
        736 to expedite the drug development process and the review of 
        human drug applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which the 
        application is complete.
    ``(d) Awareness Efforts.--The Secretary shall--
            ``(1) develop and widely disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology companies, and 
        other appropriate persons a comprehensive description of the 
        provisions applicable to fast track drugs established under 
        this section; and
            ``(2) establish an ongoing program to encourage the 
        development of surrogate endpoints that are reasonably likely 
        to predict clinical benefit for serious or life-threatening 
        conditions for which there exist significant unmet medical 
        needs.''.
    (b) Guidance.--Within 1 year after the date of enactment of this 
Act, the Secretary of Health and Human Services shall issue guidance 
for fast track drugs that describes the policies and procedures that 
pertain to section 561 of the Federal Food, Drug, and Cosmetic Act.

SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.

    (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 602, is further amended by adding at the end the following:

                 ``Subchapter E--Manufacturing Changes

``SEC. 751. MANUFACTURING CHANGES.

    ``(a) In General.--A change in the manufacture of a new drug, 
including a biological product, may be made in accordance with this 
section.
    ``(b) Changes.--
            ``(1) Validation.--Before distributing a drug made after a 
        change in the manufacture of the drug from the manufacturing 
        process established in the approved new drug application under 
        section 505, or license application under section 351 of the 
        Public Health Service Act, the applicant shall validate the 
        effect of the change on the identity, strength, quality, 
purity, and potency of the drug as the identity, strength, quality, 
purity, and potency may relate to the safety or effectiveness of the 
drug.
            ``(2) Reports.--The applicant shall report the change 
        described in paragraph (1) to the Secretary and may distribute 
        a drug made after the change as follows:
                    ``(A) Major manufacturing changes.
                            ``(i) In general.--Major manufacturing 
                        changes, which are of a type determined by the 
                        Secretary to have substantial potential to 
                        adversely affect the identity, strength, 
                        quality, purity, or potency of the drug as the 
                        identity, strength, quality, purity, and 
                        potency may relate to the safety or 
                        effectiveness of a drug, shall be submitted to 
                        the Secretary in a supplemental application and 
                        drugs made after such changes may not be 
                        distributed until the Secretary approves the 
                        supplemental application.
                            ``(ii) Definition.--In this subparagraph, 
                        the term `major manufacturing changes' means--
                                    ``(I) changes in the qualitative or 
                                quantitative formulation of a drug or 
                                the specifications in the approved 
                                marketing application for the drug 
                                (unless exempted by the Secretary from 
                                the requirements of this subparagraph);
                                    ``(II) changes that the Secretary 
                                determines by regulation or issuance of 
                                guidance require completion of an 
                                appropriate human study demonstrating 
                                equivalence of the drug to the drug 
                                manufactured before such changes; and
                                    ``(III) other changes that the 
                                Secretary determines by regulation or 
                                issuance of guidance have a substantial 
                                potential to adversely affect the 
                                safety or effectiveness of the drug.
                    ``(B) Other manufacturing changes.--
                            ``(i) In general.--As determined by the 
                        Secretary, manufacturing changes other than 
                        major manufacturing changes shall--
                                    ``(I) be made at any time and 
                                reported annually to the Secretary, 
                                with supporting data; or
                                    ``(II) be reported to the Secretary 
                                in a supplemental application.
                            ``(ii) Distribution of the drug.--In the 
                        case of changes reported in accordance with 
                        clause (i)(II)--
                                    ``(I) the applicant may distribute 
                                the drug 30 days after the Secretary 
                                receives the supplemental application 
                                unless the Secretary notifies the 
                                applicant within such 30-day period 
                                that prior approval of such 
                                supplemental application is required; 
                                and
                                    ``(II) the Secretary shall, after 
                                making the notification to the 
                                applicant under subclause (I), approve 
                                or disapprove each such supplemental 
                                application.
                            ``(iii) Special rule.--The Secretary may 
                        determine types of manufacturing changes after 
                        which distribution of a drug may commence at 
                        the time of submission of such supplemental 
                        application.''.
    (b) Existing Law.--The requirements of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.) and the Public Health Service Act 
(42 U.S.C. 201 et seq.) that are in effect on the date of enactment of 
this Act with respect to manufacturing changes shall remain in effect--
            (1) for a period of 24 months after the date of enactment 
        of this Act; or
            (2) until the effective date of regulations promulgated by 
        the Secretary of Health and Human Services implementing section 
        751 of the Federal Food, Drug, and Cosmetic Act,
whichever is sooner.

SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

    Within 12 months after the date of enactment of this Act, the 
Secretary of the Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall issue guidance that describes 
when abbreviated study reports may be submitted, in lieu of full 
reports, with a new drug application under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and with a biologics 
license application under section 351 of the Public Health Service Act 
(42 U.S.C. 262) for certain types of studies. Such guidance shall 
describe the kinds of studies for which abbreviated reports are 
appropriate and the appropriate abbreviated report formats.

SEC. 616. FOOD CONTACT SUBSTANCES.

    (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 348(a)) is 
amended--
            (1) in paragraph (1)--
                    (A) by striking ``subsection (i)'' and inserting 
                ``subsection (j)''; and
                    (B) by striking at the end ``or'';
            (2) by striking the period at the end of paragraph (2) and 
        inserting ``; or'';
            (3) by inserting after paragraph (2) the following:
            ``(3) in the case of a food additive as defined in this Act 
        that is a food contact substance, there is--
                    ``(A) in effect, and such substance and the use of 
                such substance are in conformity with, a regulation 
                issued under this section prescribing the conditions 
                under which such additive may be safely used; or
                    ``(B) a notification submitted under subsection (h) 
                that is effective.''; and
            (4) by striking the matter following paragraph (3) (as 
        added by paragraph (2)) and inserting the following flush 
        sentence:
``While such a regulation relating to a food additive, or such a 
notification under subsection (h) relating to a food additive that is a 
food contact substance, is in effect, and has not been revoked pursuant 
to subsection (i), a food shall not, by reason of bearing or containing 
such a food additive in accordance with the regulation or notification, 
be considered adulterated under section 402(a)(1).''.
    (b) Notification for Food Contact Substances.--Section 409 (21 
U.S.C. 348), as amended by subsection (a), is further amended--
            (1) by redesignating subsections (h) and (i), as 
        subsections (i) and (j), respectively;
            (2) by inserting after subsection (g) the following:

          ``Notification Relating to a Food Contact Substance

    ``(h)(1) Subject to such regulations as may be promulgated under 
paragraph (3), a manufacturer or supplier of a food contact substance 
may, at least 120 days prior to the introduction or delivery for 
introduction into interstate commerce of the food contact substance, 
notify the Secretary of the identity and intended use of the food 
contact substance, and of the determination of the manufacturer or 
supplier that the intended use of such food contact substance is safe 
under the standard described in subsection (c)(3)(A). The notification 
shall contain the information that forms the basis of the 
determination, the fee required under paragraph (5), and all 
information required to be submitted by regulations promulgated by the 
Secretary.
    ``(2)(A) A notification submitted under paragraph (1) shall become 
effective 120 days after the date of receipt by the Secretary and the 
food contact substance may be introduced or delivered for introduction 
into interstate commerce, unless the Secretary makes a determination 
within the 120-day period that, based on the data and information 
before the Secretary, such use of the food contact substance has not 
been shown to be safe under the standard described in subsection 
(c)(3)(A), and informs the manufacturer or supplier of such 
determination.
    ``(B) A decision by the Secretary to object to a notification shall 
constitute final agency action subject to judicial review.
    ``(C) In this paragraph, the term `food contact substance' means 
the substance that is the subject of a notification submitted under 
paragraph (1), and does not include a similar or identical substance 
manufactured or prepared by a person other than the manufacturer 
identified in the notification.
    ``(3)(A) The process in this subsection shall be utilized for 
authorizing the marketing of a food contact substance except where the 
Secretary determines that submission and review of a petition under 
subsection (b) is necessary to provide adequate assurance of safety, or 
where the Secretary and any manufacturer or supplier agree that such 
manufacturer or supplier may submit a petition under subsection (b).
    ``(B) The Secretary is authorized to promulgate regulations to 
identify the circumstances in which a petition shall be filed under 
subsection (b), and shall consider criteria such as the probable 
consumption of such food contact substance and potential toxicity of 
the food contact substance in determining the circumstances in which a 
petition shall be filed under subsection (b).
    ``(4) The Secretary shall keep confidential any information 
provided in a notification under paragraph (1) for 120 days after 
receipt by the Secretary of the notification. After the expiration of 
such 120 days, the information shall be available to any interested 
party except for any matter in the notification that is a trade secret 
or confidential commercial information.
    ``(5)(A) Each person that submits a notification regarding a food 
contact substance under this section shall be subject to the payment of 
a reasonable fee. The fee shall be based on the resources required to 
process the notification including reasonable administrative costs for 
such processing.
    ``(B) The Secretary shall conduct a study of the costs of 
administering the notification program established under this section 
and, on the basis of the results of such study, shall, within 18 months 
after the date of enactment of the Food and Drug Administration 
Modernization and Accountability Act of 1997, promulgate regulations 
establishing the fee required by subparagraph (A).
    ``(C) A notification submitted without the appropriate fee is not 
complete and shall not become effective for the purposes of subsection 
(a)(3) until the appropriate fee is paid.
    ``(D) Fees collected pursuant to this subsection--
            ``(i) shall not be deposited as an offsetting collection to 
        the appropriations for the Department of Health and Human 
        Services;
            ``(ii) shall be credited to the appropriate account of the 
        Food and Drug Administration; and
            ``(iii) shall be available in accordance with appropriation 
        Acts until expended, without fiscal year limitation.
    ``(6) In this section, the term `food contact substance' means any 
substance intended for use as a component of materials used in 
manufacturing, packing, packaging, transporting, or holding food if 
such use is not intended to have any technical effect in such food.'';
            (3) in subsection (i), as so redesignated by paragraph (1), 
        by adding at the end the following: ``The Secretary shall by 
        regulation prescribe the procedure by which the Secretary may 
        deem a notification under subsection (h) to no longer be 
        effective.''; and
            (4) in subsection (j), as so redesignated by paragraph (1), 
        by striking ``subsections (b) to (h)'' and inserting 
        ``subsections (b) to (i)''.
    (c) Effective Date.--Notifications under section 409(h) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (b), may 
be submitted beginning 18 months after the date of enactment of this 
Act.

SEC. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the 
end the following:
    ``(C) Notwithstanding the provisions of clauses (A)(i) and (B), a 
claim of the type described in subparagraph (1)(B) that is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause (B) shall be authorized and may be made if--
            ``(i) an authoritative scientific body of the Federal 
        Government with official responsibility for public health 
        protection or research directly relating to human nutrition 
        (such as the National Institutes of Health or the Centers for 
        Disease Control and Prevention), the National Academy of 
        Sciences, or a subdivision of the scientific body or the 
        National Academy of Sciences, has published an authoritative 
        statement, which is currently in effect, about the relationship 
        between a nutrient and a disease or health-related condition to 
        which the claim refers;
            ``(ii) a person has submitted to the Secretary at least 90 
        days before the first introduction of a food into interstate 
        commerce a notice of the claim, including a concise description 
        of the basis upon which such person relied for determining that 
        the requirements of subclause (i) have been satisfied;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clause (A)(ii), and are otherwise in 
        compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.
For purposes of this paragraph, a statement shall be regarded as an 
authoritative statement of such a scientific body described in 
subclause (i) only if the statement is published by the scientific body 
and shall not include a statement of an employee of the scientific body 
made in the individual capacity of the employee.
    ``(D) A claim meeting the requirements of clause (C) may be made 
until--
            ``(i) such time as the Secretary issues a final regulation 
        under clause (B) prohibiting or modifying the claim, and the 
        regulation has become effective; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (C) have not been met.''.

SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 505 the following:

``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

    ``(a) Market Exclusivity for New Drugs.--If, prior to approval of 
an application that is submitted under section 505(b)(1) the Secretary 
determines that information relating to the use of a drug in the 
pediatric population may produce health benefits in that population, 
the Secretary makes a written request for pediatric studies (which may 
include a timeframe for completing such studies), and such studies are 
completed within any such timeframe and the reports thereof submitted 
in accordance with subsection (d)(2) or completed within any such 
timeframe and the reports thereof are accepted in accordance with 
subsection (d)(3)--
            ``(1)(A) the period during which an application may not be 
        submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 shall be five years and six months rather than five 
        years, and the references in subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(B) the period of market exclusivity under subsections 
        (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
        section 505 shall be three years and six months rather than 
        three years; and
            ``(2)(A) if the drug is the subject of--
                    ``(i) a listed patent for which a certification has 
                been submitted under section 505(b)(2)(A)(ii) or 
                section (j)(2)(A)(vii)(II) and for which pediatric 
                studies were submitted prior to the expiration of the 
                patent (including any patent extensions); or
                    ``(ii) a listed patent for which a certification 
                has been submitted under section 505(b)(2)(A)(iii) or 
                section 505(j)(2)(A)(vii)(III),
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
            ``(B) if the drug is the subject of a listed patent for   
        which   a   certification   has   been   submitted under 
        section 505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), and 
        in the patent infringement litigation resulting from the 
        certification the court determines that the patent is valid and 
        would be infringed, the period during which an application may 
        not be approved under section 505(c)(3) or section 505(j)(4)(B) 
        shall be extended by a period of six months after the date the 
        patent expires (including any patent extensions).
    ``(b) Secretary To Develop List of Drugs for Which Additional 
Pediatric Information May Be Beneficial.--Not later than 180 days after 
the date of enactment of this section, the Secretary, after 
consultation with experts in pediatric research (such as the American 
Academy of Pediatrics, the Pediatric Pharmacology Research Unit 
Network, and the United States Pharmacopoeia) shall develop, 
prioritize, and publish an initial list of approved drugs for which 
additional pediatric information may produce health benefits in the 
pediatric population. The Secretary shall annually update the list.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--If the 
Secretary makes a written request for pediatric studies (which may 
include a timeframe for completing such studies) concerning a drug 
identified in the list described in subsection (b) to the holder of an 
approved application under section 505(b)(1) for the drug, the holder 
agrees to the request, and the studies are completed within any such 
timeframe and the reports thereof submitted in accordance with 
subsection (d)(2) or completed within any such timeframe and the 
reports thereof accepted in accordance with subsection (d)(3)--
            ``(1)(A) the period during which an application may not be 
        submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 shall be five years and six months rather than five 
        years, and the references in subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(B) the period of market exclusivity under subsections 
        (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
        section 505 shall be three years and six months rather than 
        three years; and
            ``(2)(A) if the drug is the subject of--
                    ``(i) a listed patent for which a certification has 
                been submitted under section 505(b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) and for which pediatric studies were 
                submitted prior to the expiration of the patent 
                (including any patent extensions); or
                    ``(ii) a listed patent for which a certification 
                has been submitted under section 505(b)(2)(A)(iii) or 
                section 505(j)(2)(A)(vii)(III),
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
            ``(B) if the drug is the subject of a listed patent for 
        which a certification has been submitted under section 
        505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions).
    ``(d) Conduct of Pediatric Studies.--
            ``(1) Agreement for studies.--The Secretary may, pursuant 
        to a written request for studies, after consultation with--
                    ``(A) the sponsor of an application for an 
                investigational new drug under section 505(i);
                    ``(B) the sponsor of an application for a drug 
                under section 505(b)(1); or
                    ``(C) the holder of an approved application for a 
                drug under section 505(b)(1),
        agree with the sponsor or holder for the conduct of pediatric 
        studies for such drug.
            ``(2) Written protocols to meet the studies requirement.--
        If the sponsor or holder and the Secretary agree upon written 
        protocols for the studies, the studies requirement of 
        subsection (a) or (c) is satisfied upon the completion of the 
        studies and submission of the reports thereof in accordance 
        with the original written request and the written agreement 
        referred to in paragraph (1). Not later than 60 days after the 
        submission of the report of the studies, the Secretary shall 
        determine if such studies were or were not conducted in 
        accordance with the original written request and the written 
        agreement and reported in accordance with the requirements of 
        the Secretary for filing and so notify the sponsor or holder.
            ``(3) Other methods to meet the studies requirement.--If 
        the sponsor or holder and the Secretary have not agreed in 
        writing on the protocols for the studies, the studies 
        requirement of subsection (a) or (c) is satisfied when such 
        studies have been completed and the reports accepted by the 
        Secretary. Not later than 90 days after the submission of the 
        reports of the studies, the Secretary shall accept or reject 
        such reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or rejecting the 
        reports shall be to determine, within the 90 days, whether the 
        studies fairly respond to the written request, whether such 
        studies have been conducted in accordance with commonly 
        accepted scientific principles and protocols, and whether such 
        studies have been reported in accordance with the requirements 
        of the Secretary for filing.
    ``(e) Delay of Effective Date for Certain Applications; Period of 
Market Exclusivity.--If the Secretary determines that the acceptance or 
approval of an application under section 505(b)(2) or 505(j) for a drug 
may occur after submission of reports of pediatric studies under this 
section, which were submitted prior to the expiration of the patent 
(including any patent extension) or market exclusivity protection, but 
before the Secretary has determined whether the requirements of 
subsection (d) have been satisfied, the Secretary shall delay the 
acceptance or approval under section 505(b)(2) or 505(j), respectively, 
until the determination under subsection (d) is made, but such delay 
shall not exceed 90 days. In the event that requirements of this 
section are satisfied, the applicable period of market exclusivity 
referred to in subsection (a) or (c) shall be deemed to have been 
running during the period of delay.
    ``(f) Notice of Determinations on Studies Requirement.--The 
Secretary shall publish a notice of any determination that the 
requirements of subsection (d) have been met and that submissions and 
approvals under section 505(b)(2) or (j) for a drug will be subject to 
the provisions of this section.
    ``(g) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least 1 clinical investigation (that, at 
the Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age-groups in which a drug is anticipated to be used.
    ``(h) Limitation.--The holder of an approved application for a new 
drug that has already received six months of market exclusivity under 
subsection (a) or (c) may, if otherwise eligible, obtain six months of 
market exclusivity under subsection (c)(1)(B) for a supplemental 
application, except that the holder is not eligible for exclusivity 
under subsection (c)(2).
    ``(i) Sunset.--No period of market exclusivity shall be granted 
under this section based on studies commenced after January 1, 2004. 
The Secretary shall conduct a study and report to Congress not later 
than January 1, 2003 based on the experience under the program. The 
study and report shall examine all relevant issues, including--
            ``(1) the effectiveness of the program in improving 
        information about important pediatric uses for approved drugs;
            ``(2) the adequacy of the incentive provided under this 
        section;
            ``(3) the economic impact of the program; and
            ``(4) any suggestions for modification that the Secretary 
        deems appropriate.''.

SEC. 619. POSITRON EMISSION TOMOGRAPHY.

    (a) Regulation of Compounded Positron Emission Tomography Drugs 
Under the Federal Food, Drug, and Cosmetic Act.--
            (1) Definition.--Section 201 (21 U.S.C. 321), as amended by 
        section 405, is further amended by adding at the end the 
        following:
    ``(jj) The term `compounded positron emission tomography drug' 
means a drug that--
            ``(1) exhibits spontaneous disintegration of unstable 
        nuclei, including the emission of positrons;
            ``(2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target material, 
        electronic synthesizer, or other apparatus or computer program 
        to be used in the preparation of any such drug; and
            ``(3)(A) has been compounded in a State in accordance with 
        State law for a patient or for research, teaching, or quality 
        control by or on the order of a practitioner licensed by that 
        State to compound or order such a drug; or
            ``(B) has been compounded in a Federal facility in a State 
        in accordance with the law of the State in which the facility 
        is located.''.
    (b) Regulation as a Drug.--Section 501(a)(2) (21 U.S.C. 351(a)(2)) 
is amended by striking ``; or (3)'' and inserting the following: ``; or 
(C) if it is a compounded positron emission tomography drug and the 
methods used in, or the facilities and controls used for, its 
compounding, processing, packing, or holding do not conform to or are 
not operated or administered in conformity with the positron emission 
tomography compounding standards and the official monographs of the 
United States Pharmacopoeia to assure that such drug meets the 
requirements of this Act as to safety and has the identity and 
strength, and meets the quality and purity characteristics, which it 
purports or is represented to possess; or (3)''.
    (c) Regulation as a New Drug.--Section 505 (21 U.S.C. 355) is 
amended by adding at the end the following:
    ``(n) The provisions of subsections (a) and (j) shall not apply to 
the preparation of a compounded positron emission tomography drug.''.
    (d) Revocation of Certain Inconsistent Documents.--Not later than 
30 days after the date of enactment of this Act, the Secretary of 
Health and Human Services shall publish in the Federal Register a 
notice revoking--
            (1) a notice entitled ``Regulation of Positron Emission 
        Tomographic Drug Products: Guidance; Public Workshop'', 
        published in the Federal Register of February 27, 1995;
            (2) a notice entitled ``Guidance for Industry: Current Good 
        Manufacturing Practices for Positron Emission Tomographic (PET) 
        Drug Products'', published in the Federal Register of April 22, 
        1997; and
            (3) a final rule entitled ``Current Good Manufacturing 
        Practice for Finished Pharmaceuticals; Positron Emission 
        Tomography'', published in the Federal Register of April 22, 
        1997.

                   TITLE VII--FEES RELATING TO DRUGS

SEC. 701. SHORT TITLE.

    This title may be cited as the ``Prescription Drug User Fee 
Reauthorization Act of 1997''.

SEC. 702. FINDINGS.

    Congress finds that--
            (1) prompt approval of safe and effective new drugs and 
        other therapies is critical to the improvement of the public 
        health so that patients may enjoy the benefits provided by 
        these therapies to treat and prevent illness and disease;
            (2) the public health will be served by making additional 
        funds available for the purpose of augmenting the resources of 
        the Food and Drug Administration that are devoted to the 
        process for review of human drug applications;
            (3) the provisions added by the Prescription Drug User Fee 
        Act of 1992 have been successful in substantially reducing 
        review times for human drug applications and should be--
                    (A) reauthorized for an additional 5 years, with 
                certain technical improvements; and
                    (B) carried out by the Food and Drug Administration 
                with new commitments to implement more ambitious and 
                comprehensive improvements in regulatory processes of 
                the Food and Drug Administration; and
            (4) the fees authorized by amendments made in this title 
        will be dedicated toward expediting the drug development 
        process and the review of human drug applications as set forth 
        in the goals identified in the letters of ______________, and 
        ______________, from the Secretary of Health and Human Services 
        to the chairman of the Committee on Commerce of the House of 
        Representatives and the chairman of the Committee on Labor and 
        Human Resources of the Senate, as set forth at ____ Cong. Rec. 
        ________ (daily ed. __________, 1997).

SEC. 703. DEFINITIONS.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) in the second sentence of paragraph (1)--
                    (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                    (B) by striking ``September 1, 1992.'' and 
                inserting the following: ``September 1, 1992, does not 
                include an application for a licensure of a biological 
                product for further manufacturing use only, and does 
                not include an application or supplement submitted by a 
                State or Federal Government entity for a drug or 
                biological product that is not distributed 
                commercially. Such term does include an application for 
                licensure, as described in subparagraph (D), of a large 
                volume biological product intended for single dose 
                injection for intravenous use or infusion.'';
            (2) in the second sentence of paragraph (3)--
                    (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                    (B) by striking ``September 1, 1992.'' and 
                inserting the following: ``September 1, 1992, does not 
                include a biological product that is licensed for 
                further manufacturing use only, and does not include a 
                drug or biological product that is not distributed 
                commercially and is the subject of an application or 
                supplement submitted by a State or Federal Government 
                entity. Such term does include a large volume 
biological product intended for single dose injection for intravenous 
use or infusion.'';
            (3) in paragraph (4), by striking ``without'' and inserting 
        ``without substantial'';
            (4) in paragraph (7)(A)--
                    (A) by striking ``employees under contract'' and 
                all that follows through ``Administration,'' and 
                inserting ``contractors of the Food and Drug 
                Administration,''; and
                    (B) by striking ``and committees,'' and inserting 
                ``and committees and to contracts with such 
                contractors,'';
            (5) in paragraph (8)--
                    (A) in subparagraph (A)--
                            (i) by striking ``August of'' and inserting 
                        ``April of''; and
                            (ii) by striking ``August 1992'' and 
                        inserting ``April 1997'';
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) 1 plus the total percentage increase for such 
                fiscal year since fiscal year 1997 in basic pay under 
                the General Schedule in accordance with section 5332 of 
                title 5, United States Code, as adjusted by any 
                locality-based comparability payment pursuant to 
                section 5304 of such title for Federal employees 
                stationed in the District of Columbia.''; and
                    (C) by striking the second sentence; and
            (6) by adding at the end the following:
            ``(9) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) 1 business entity controls, or has the power 
                to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control both of the business entities.''.

SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) by striking ``Beginning in fiscal year 1993'' and 
        inserting ``Beginning in fiscal year 1998'';
            (2) in paragraph (1)--
                    (A) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) Payment.--The fee required by subparagraph 
                (A) shall be due upon submission of the application or 
                supplement.'';
                    (B) in subparagraph (D)--
                            (i) in the subparagraph heading, by 
                        striking ``not accepted'' and inserting 
                        ``refused'';
                            (ii) by striking ``50 percent'' and 
                        inserting ``75 percent'';
                            (iii) by striking ``subparagraph (B)(i)'' 
                        and inserting ``subparagraph (B)''; and
                            (iv) by striking ``not accepted'' and 
                        inserting ``refused''; and
                    (C) by adding at the end the following:
                    ``(E) Exception for designated orphan drug or 
                indication.--A person that submits a human drug 
                application for a prescription drug product that has 
                been designated as a drug for a rare disease or 
                condition pursuant to section 526, or a supplement 
                proposing to include a new indication for a rare 
                disease or condition pursuant to section 526, shall not 
                be assessed a fee under subparagraph (A), unless the 
                human drug application includes indications for other 
                than rare diseases or conditions.
                    ``(F) Exception for applications and supplements 
                for pediatric indications.--A person that submits a 
                human drug application or supplement that includes an 
                indication for use in pediatric populations shall be 
assessed a fee under subparagraph (A) only if--
                            ``(i) the application is for initial 
                        approval for use in a pediatric population; or
                            ``(ii) the application or supplement is for 
                        approval for use in pediatric and non-pediatric 
                        populations.
                    ``(G) Refund of fee if application withdrawn.--If 
                an application or supplement is withdrawn after the 
                application or supplement is filed, the Secretary may 
                waive and refund the fee or a portion of the fee if no 
                substantial work was performed on the application or 
                supplement after the application or supplement was 
                filed. The Secretary shall have the sole discretion to 
                waive and refund a fee or a portion of the fee under 
                this subparagraph. A determination by the Secretary 
                concerning a waiver or refund under this paragraph 
                shall not be reviewable.'';
            (3) in paragraph (2)(A), by striking ``505(j), and'' and 
        inserting the following: ``505(j) or under an abbreviated new 
        drug application pursuant to regulations in effect prior to the 
        implementation of the Drug Price Competition and Patent Term 
        Restoration Act of 1984, or a product approved under an 
        application filed under section 507 that is abbreviated, and''; 
        and
            (4) in paragraph (3)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``is 
                        listed'' and inserting ``has been submitted for 
                        listing''; and
                            (ii) by striking ``Such fee shall be 
                        payable'' and all that follows through 
                        ``section 510.'' and inserting the following: 
                        ``Such fee shall be payable for the fiscal year 
                        in which the product is first submitted for 
                        listing under section 510, or for relisting 
                        under section 510 if the product has been 
                        withdrawn from listing and relisted. After such 
                        fee is paid for that fiscal year, such fee 
                        shall be payable on or before January 31 of 
                        each year. Such fee shall be paid only once for 
                        each product for a fiscal year in which the fee 
                        is payable.''; and
                    (B) in subparagraph (B), by striking ``505(j).'' 
                and inserting the following: ``505(j), or under an 
                abbreviated new drug application pursuant to 
                regulations in effect prior to the implementation of 
                the Drug Price Competition and Patent Term Restoration 
                Act of 1984, or is a product approved under an 
                application filed under section 507 that is 
                abbreviated.''.
    (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is amended to 
read as follows:
    ``(b) Fee Amounts.--Except as provided in subsections (c), (d), 
(f), and (g), the fees required under subsection (a) shall be 
determined and assessed as follows:
            ``(1) Application and supplement fees.--
                    ``(A) Full fees.--The application fee under 
                subsection (a)(1)(A)(i) shall be $250,704 in fiscal 
                year 1998, $256,338 in each of fiscal years 1999 and 
                2000, $267,606 in fiscal year 2001, and $258,451 in 
                fiscal year 2002.
                    ``(B) Other fees.--The fee under subsection 
                (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, 
                $128,169 in each of fiscal years 1999 and 2000, 
                $133,803 in fiscal year 2001, and $129,226 in fiscal 
                year 2002.
            ``(2) Fee revenues for establishment fees.--The total fee 
        revenues to be collected in establishment fees under subsection 
        (a)(2) shall be $35,600,000 in fiscal year 1998, $36,400,000 in 
        each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 
        2001, and $36,700,000 in fiscal year 2002.
            ``(3) Total fee revenues for product fees.--The total fee 
        revenues to be collected in product fees under subsection 
        (a)(3) in a fiscal year shall be equal to the total fee 
        revenues collected in establishment fees under subsection 
        (a)(2) in that fiscal year.''.
    (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 379h(c)) 
is amended--
            (1) in the subsection heading, by striking ``Increases 
        and'';
            (2) in paragraph (1)--
                    (A) by striking ``(1) Revenue'' and all that 
                follows through ``increased by the Secretary'' and 
                inserting the following: ``(1) Inflation adjustment.--
                The fees and total fee revenues established in 
                subsection (b) shall be adjusted by the Secretary'';
                    (B) in subparagraph (A), by striking ``increase'' 
                and inserting ``change'';
                    (C) in subparagraph (B), by striking ``increase'' 
                and inserting ``change''; and
                    (D) by adding at the end the following flush 
                sentence:
        ``The adjustment made each fiscal year by this subsection will 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 1997 under this 
        subsection.'';
            (3) in paragraph (2), by striking ``October 1, 1992,'' and 
        all that follows through ``such schedule.'' and inserting the 
        following: ``September 30, 1997, adjust the establishment and 
        product fees described in subsection (b) for the fiscal year in 
        which the adjustment occurs so that the revenues collected from 
        each of the categories of fees described in paragraphs (2) and 
        (3) of subsection (b) shall be set to be equal to the revenues 
        collected during the past fiscal year from the category of 
        application and supplement fees described in paragraph (1) of 
        subsection (b).''; and
            (4) in paragraph (3), by striking ``paragraph (2)'' and 
        inserting ``this subsection''.
    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) by redesignating paragraphs (1), (2), (3), and (4) as 
        subparagraphs (A), (B), (C), and (D), respectively and 
        indenting appropriately;
            (2) by striking ``The Secretary shall grant a'' and all 
        that follows through ``finds that--'' and inserting the 
        following:
            ``(1) In general.--The Secretary shall grant a waiver from 
        or a reduction of 1 or more fees assessed under subsection (a) 
        where the Secretary finds that--'';
            (3) in subparagraph (C) (as so redesignated by paragraph 
        (1)), by striking ``, or'' and inserting a comma;
            (4) in subparagraph (D) (as so redesignated by paragraph 
        (1)), by striking the period and inserting ``, or'';
            (5) by inserting after subparagraph (D) (as so redesignated 
        by paragraph (1)) the following:
                    ``(E) the applicant is a small business submitting 
                its first human drug application to the Secretary for 
                review.''; and
            (6) by striking ``In making the finding in paragraph (3),'' 
        and all that follows through ``standard costs.'' and inserting 
        the following:
            ``(2) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard costs.
            ``(3) Rules relating to small businesses.--
                    ``(A) Definition.--In paragraph (1)(E), the term 
                `small business' means an entity that has fewer than 
                500 employees, including employees of affiliates.
                    ``(B) Waiver of application fee.--The Secretary 
                shall waive under paragraph (1)(E) the application fee 
                for the first human drug application that a small 
                business or its affiliate submits to the Secretary for 
                review. After a small business or its affiliate is 
                granted such a waiver, the small business or its 
                affiliate shall pay--
                            ``(i) application fees for all subsequent 
                        human drug applications submitted to the 
                        Secretary for review in the same manner as an 
                        entity that does not qualify as a small 
                        business; and
                            ``(ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review in the 
                        same manner as an entity that does not qualify 
                        as a small business.''.
    (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 379h(f)(1)) 
is amended--
            (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
        year 1997''; and
            (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
        year 1997 (excluding the amount of fees appropriated for such 
        fiscal year)''.
    (f) Crediting and Availability of Fees.--Section 736(g) (21 U.S.C. 
379h(g)) is amended--
            (1) in paragraph (1), by adding at the end the following: 
        ``Such sums as may be necessary may be transferred from the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the review of human drug 
        applications within the meaning of section 735(6).'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``Acts'' and 
                inserting ``Acts, or otherwise made available for 
                obligation,''; and
                    (B) in subparagraph (B), by striking ``over such 
                costs for fiscal year 1992'' and inserting ``over such 
                costs, excluding costs paid from fees collected under 
                this section, for fiscal year 1997''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated for fees under this section--
                    ``(A) $106,800,000 for fiscal year 1998;
                    ``(B) $109,200,000 for fiscal year 1999;
                    ``(C) $109,200,000 for fiscal year 2000;
                    ``(D) $114,000,000 for fiscal year 2001; and
                    ``(E) $110,100,000 for fiscal year 2002,
        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by application, supplement, establishment, and 
        product fees.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year which exceeds the amount of fees specified in 
        appropriation Acts for such fiscal year, shall be credited to 
        the appropriation account of the Food and Drug Administration 
        as provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under appropriation Acts for a subsequent fiscal 
        year.''.
    (g) Requirement for Written Requests for Waivers, Reductions, and 
Fees.--Section 736 (21 U.S.C. 379h) is amended--
            (1) by redesignating subsection (i) as subsection (j); and
            (2) by inserting after subsection (h) the following:
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund, of any fee collected in accordance with 
subsection (a), a person shall submit to the Secretary a written 
request for such waiver, reduction, or refund not later than 180 days 
after such fee is due.''.
    (h) Special Rule for Waiver, Refunds, and Exceptions.--Any requests 
for waivers, refunds, or exceptions for fees paid prior to the date of 
enactment of this Act shall be submitted in writing to the Secretary of 
Health and Human Services within 1 year after the date of enactment of 
this Act.

SEC. 705. ANNUAL REPORTS.

    (a) First Report.--Beginning with fiscal year 1998, not later than 
60 days after the end of each fiscal year during which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report concerning the progress of the 
Food and Drug Administration in achieving the goals identified in the 
letter described in section 702(4) during such fiscal year and the 
future plans of the Food and Drug Administration for meeting the goals.
    (b) Second Report.--Beginning with fiscal year 1998, not later than 
120 days after the end of each fiscal year during which fees are 
collected under the part described in subsection (a), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report on the implementation of the 
authority for such fees during such fiscal year and the use, by the 
Food and Drug Administration, of the fees collected during such fiscal 
year for which the report is made.

SEC. 706. EFFECTIVE DATE.

    The amendments made by this title shall take effect October 1, 
1997.

SEC. 707. TERMINATION OF EFFECTIVENESS.

    The amendments made by sections 703 and 704 cease to be effective 
October 1, 2002 and section 705 ceases to be effective 120 days after 
such date.

                       TITLE VIII--MISCELLANEOUS

SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.

    Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows:
    ``(i)(1) Any establishment within any foreign country engaged in 
the manufacture, preparation, propagation, compounding, or processing 
of a drug or a device that is imported or offered for import into the 
United States shall register with the Secretary the name and place of 
business of the establishment and the name of the United States agent 
for the establishment.
    ``(2) The establishment shall also provide the information required 
by subsection (j).
    ``(3) The Secretary is authorized to enter into cooperative 
arrangements with foreign countries to ensure that adequate and 
effective means are available for purposes of determining, from time to 
time, whether drugs or devices manufactured, prepared, propagated, 
compounded, or processed by an establishment described in paragraph 
(1), if imported or offered for import into the United States, shall be 
refused admission on any of the grounds set forth in section 801(a).''.

SEC. 802. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

    (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 353(b)(4)) is 
amended to read as follows:
    ``(4)(A) A drug that is subject to paragraph (1) shall be deemed to 
be misbranded if at any time prior to dispensing the label of the drug 
fails to bear, at a minimum, the symbol `Rx only'.
    ``(B) A drug to which paragraph (1) does not apply shall be deemed 
to be misbranded if at any time prior to dispensing the label of the 
drug bears the symbol described in subparagraph (A).''.
    (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
repealed.
    (c) Conforming Amendments.--
            (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
                    (A) by striking subparagraph (A); and
                    (B) by redesignating subparagraphs (B) and (C) as 
                subparagraphs (A) and (B), respectively.
            (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
        striking ``section 502(d) and''.
            (3) Section 102(9)(A) of the Controlled Substances Act (21 
        U.S.C. 802(9)(A)) is amended--
                    (A) in clause (i), by striking ``(i)''; and
                    (B) by striking ``(ii)'' and all that follows.

SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.

    Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
            (1) in paragraph (1), in the fifth sentence, by striking 
        ``paragraphs (1) and (2) of section 801(e)'' and inserting 
        ``subparagraphs (A) and (B) of section 801(e)(1)''; and
            (2) by inserting after the fifth sentence the following: 
        ``Any person seeking to export an imported article pursuant to 
        any of the provisions of this subsection shall establish that 
        the article was intended for export at the time the article 
        entered commerce.''.

SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 203, is 
further amended by adding at the end the following:

``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

    ``(a) In General.--The Secretary, acting through the Commissioner 
of Food and Drugs, may, directly or through grants, contracts, or 
cooperative agreements, conduct and support intramural research 
training in regulatory scientific programs by predoctoral and 
postdoctoral scientists and physicians, including the support through 
the use of fellowships.
    ``(b) Limitation on Participation.--A recipient of a fellowship 
under subsection (a) may not be an employee of the Federal Government.
    ``(c) Special Rule.--The Secretary, acting through the Commissioner 
of Food and Drugs, may support the provision of assistance for 
fellowships described in subsection (a) through a Cooperative Research 
and Development Agreement.''.

SEC. 805. DEVICE SAMPLES.

    (a) Recall Authority.--
            (1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2)) 
        is amended by adding at the end the following:
    ``(C) If the Secretary issues an amended order under subparagraph 
(A), the Secretary may require the person subject to the order to 
submit such samples of the device and of components of the device as 
the Secretary may reasonably require. If the submission of such samples 
is impracticable or unduly burdensome, the requirement of this 
subparagraph may be met by the submission of complete information 
concerning the location of 1 or more such devices readily available for 
examination and testing.''.
            (2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C. 
        360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and 
        (C)'' and inserting ``subparagraph (B)''.
    (b) Records and Reports on Devices.--Section 519(a) (21 U.S.C. 
360i(a)) is amended by inserting after paragraph (9) the following:
            ``(10) may reasonably require a manufacturer, importer, or 
        distributor to submit samples of a device and of components of 
        the device that may have caused or contributed to a death or 
        serious injury, except that if the submission of such samples 
        is impracticable or unduly burdensome, the requirement of this 
        paragraph may be met by the submission of complete information 
        concerning the location of 1 or more such devices readily 
        available for examination and testing.''.

SEC. 806. INTERSTATE COMMERCE.

    Section 709 (21 U.S.C. 379a) is amended by striking ``a device'' 
and inserting ``a device, food, drug, or cosmetic''.

SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 614, is 
further amended by adding at the end the following:

``Subchapter F--National Uniformity for Nonprescription Drugs for Human 
                           Use and Cosmetics

``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
              COSMETICS.

    ``(a) In General.--Except as provided in subsection (b), (c)(1), or 
(d), no State or political subdivision of a State may establish or 
continue in effect any requirement--
            ``(1) that relates to the regulation of a drug intended for 
        human use that is not subject to the requirements of section 
        503(b)(1) or a cosmetic; and
            ``(2) that is different from or in addition to, or that is 
        otherwise not identical with, a requirement of this Act, the 
        Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
        seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 
        et seq.).
    ``(b) Exemption.--Upon application of a State, the Secretary may by 
regulation, after notice and opportunity for written and oral 
presentation of views, exempt from subsection (a), under such condition 
as may be prescribed in such regulation, a State requirement that--
            ``(1) protects an important public interest that would 
        otherwise be unprotected;
            ``(2) would not cause any drug or cosmetic to be in 
        violation of any applicable requirement or prohibition under 
        Federal law; and
            ``(3) would not unduly burden interstate commerce.
    ``(c) Scope.--For purposes of subsection (a), a requirement that 
relates to the regulation of a drug or cosmetic--
            ``(1) shall not include any requirement that relates to the 
        practice of pharmacy or any requirement that a drug be 
        dispensed only upon the prescription of a practitioner licensed 
        by law to administer such drug; and
            ``(2) shall be deemed to include any requirement relating 
        to public information or any other form of public communication 
        relating to the safety or effectiveness of a drug or cosmetic.
    ``(d) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any 
State.''.

SEC. 808. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR LIFE-
              THREATENING DISEASES.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended--
            (1) by redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
            (2) by inserting after subsection (i), the following:
    ``(j)(1) The Secretary, acting through the Director of the National 
Institutes of Health and subject to the availability of appropriations, 
shall establish, maintain, and operate a program with respect to 
information on research relating to the treatment, detection, and 
prevention of serious or life-threatening diseases and conditions. The 
program shall, with respect to the agencies of the Department of Health 
and Human Services, be integrated and coordinated, and, to the extent 
practicable, coordinated with other data banks containing similar 
information.
    ``(2)(A) After consultation with the Commissioner of Food and 
Drugs, the directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of Medicine), and 
the Director of the Centers for Disease Control and Prevention, the 
Secretary shall, in carrying out paragraph (1), establish a data bank 
of information on clinical trials for drugs, and biologicals, for 
serious or life-threatening diseases and conditions.
    ``(B) In carrying out subparagraph (A), the Secretary shall 
collect, catalog, store and disseminate the information described in 
such subparagraph. The Secretary shall disseminate such information 
through information systems, which shall include toll-free telephone 
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to 
health care providers, and to researchers.
    ``(3) The Data Bank shall include the following:
            ``(A) A registry of clinical trials (whether federally or 
        privately funded) of experimental treatments for serious or 
        life-threatening diseases and conditions under regulations 
        promulgated pursuant to sections 505 and 520 of the Federal 
        Food, Drug, and Cosmetic Act that provides a description of the 
        purpose of each experimental drug or biological protocol, 
        either with the consent of the protocol sponsor, or when a 
        trial to test efficacy begins. Information provided shall 
        consist of eligibility criteria, a description of the location 
        of trial sites, and a point of contact for those wanting to 
        enroll in the trial, and shall be in a form that can be readily 
        understood by members of the public. Such information must be 
        forwarded to the Data Bank by the sponsor of the trial not 
        later than 21 days after the approval by the Food and Drug 
        Administration.
            ``(B) Information pertaining to experimental treatments for 
        serious or life-threatening diseases and conditions that may be 
        available--
                    ``(i) under a treatment investigational new drug 
                application that has been submitted to the Food and 
                Drug Administration pursuant to part 312 of title 21, 
                Code of Federal Regulations; or
                    ``(ii) as a Group C cancer drug.
        The Data Bank may also include information pertaining to the 
        results of clinical trials of such treatments, with the consent 
        of the sponsor, including information concerning potential 
        toxicities or adverse effects associated with the use or 
        administration of such experimental treatments.
    ``(4) The Data Bank shall not include information relating to an 
investigation if the sponsor has certified to the Secretary that 
disclosure of such information would substantially interfere with the 
timely enrollment of subjects in the investigation.
    ``(5) For the purpose of carrying out this subsection, there are 
authorized to be appropriated such sums as may be necessary. Fees 
collected under section 736 of the Federal Food, Drug, and Cosmetic (21 
U.S.C. 379h) shall not be authorized or appropriated for use in 
carrying out this subsection.''.
    (b) Collaboration and Report.--
            (1) In general.--The Secretary of Health and Human 
        Services, the Director of the National Institutes of Health, 
        and the Commissioner of Food and Drugs shall collaborate to 
        determine the feasibility of including device investigations 
        within the scope of the registry requirements set forth in 
        subsection (j) of section 402 of the Public Health Service Act.
            (2) Report.--Not later than 2 years after the date of 
        enactment of this section, the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on Labor and 
        Human Resources of the Senate and the Committee on Commerce of 
        the House of Representatives a report that shall consider, 
        among other things--
                    (A) the public health need, if any, for inclusion 
                of device investigations within the scope of the 
                registry requirements set forth in subsection (j) of 
                section 402 of the Public Health Service Act; and
                    (B) the adverse impact, if any, on device 
                innovation and research in the United States if 
                information relating to such device investigations is 
                required to be publicly disclosed.

SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF PHARMACY 
              COMPOUNDING.

    Section 503 (21 U.S.C. 353) is amended by adding at the end the 
following:
    ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 507 
shall not apply to a drug product if--
            ``(A) the drug product is compounded for an identified 
        individual patient, based on a medical need for a compounded 
        product--
                    ``(i) by a licensed pharmacist in a State licensed 
                pharmacy or a Federal facility, or a licensed 
                physician, on the prescription order of a licensed 
                physician or other licensed practitioner authorized by 
                State law to prescribe drugs; or
                    ``(ii) by a licensed pharmacist or licensed 
                physician in limited quantities, prior to the receipt 
                of a valid prescription order for the identified 
                individual patient, and is compounded based on a 
                history of the licensed pharmacist or licensed 
                physician receiving valid prescription orders for the 
                compounding of the drug product that have been 
                generated solely within an established relationship 
                between the licensed pharmacist, or licensed physician, 
                and--
                            ``(I) the individual patient for whom the 
                        prescription order will be provided; or
                            ``(II) the physician or other licensed 
                        practitioner who will write such prescription 
                        order; and
            ``(B) the licensed pharmacist or licensed physician--
                    ``(i) compounds the drug product using bulk drug 
                substances--
                            ``(I) that--
                                    ``(aa) comply with the standards of 
                                an applicable United States 
                                Pharmacopeia monograph; or
                                    ``(bb) in a case in which such a 
                                monograph does not exist, are drug 
                                substances that are covered by 
                                regulations issued by the Secretary 
                                under paragraph (3);
                            ``(II) that are manufactured by an 
                        establishment that is registered under section 
                        510 (including a foreign establishment that is 
                        registered under section 510(i)); and
                            ``(III) that are accompanied by valid 
                        certificates of analysis for each bulk drug 
                        substance;
                    ``(ii) compounds the drug product using ingredients 
                (other than bulk drug substances) that comply with the 
                standards of an applicable United States Pharmacopeia 
                monograph and the United States Pharmacopeia chapter on 
                pharmacy compounding;
                    ``(iii) only advertises or promotes the compounding 
                service provided by the licensed pharmacist or licensed 
                physician and does not advertise or promote the 
                compounding of any particular drug, class of drug, or 
                type of drug;
                    ``(iv) does not compound a drug product that 
                appears on a list published by the Secretary in the 
                Federal Register of drug products that have been 
                withdrawn or removed from the market because such drug 
                products or components of such drug products have been 
                found to be unsafe or not effective;
                    ``(v) does not compound a drug product that is 
                identified by the Secretary in regulation as presenting 
                demonstrable difficulties for compounding that 
                reasonably demonstrate an adverse effect on the safety 
                or effectiveness of that drug product; and
                    ``(vi) does not distribute compounded drugs outside 
                of the State in which the drugs are compounded, unless 
                the principal State agency of jurisdiction that 
                regulates the practice of pharmacy in such State has 
                entered into a memorandum of understanding with the 
                Secretary (based on the adequate regulation of 
                compounding performed in the State) that provides for 
                appropriate investigation by the State agency of 
                complaints relating to compounded products distributed 
                outside of the State.
    ``(2)(A) The Secretary shall, after consultation with the National 
Association of Boards of Pharmacy, develop a standard memorandum of 
understanding for use by States in complying with paragraph (1)(B)(vi).
    ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed pharmacist 
or licensed physician, who does not distribute inordinate amounts of 
compounded products outside of the State, until--
            ``(i) the date that is 180 days after the development of 
        the standard memorandum of understanding; or
            ``(ii) the date on which the State agency enters into a 
        memorandum of understanding under paragraph (1)(B)(vi),
whichever occurs first.
    ``(3) The Secretary, after consultation with the United States 
Pharmacopeia Convention Incorporated, shall promulgate regulations 
limiting compounding under paragraph (1)(B)(i)(I)(bb) to drug 
substances that are components of drug products approved by the 
Secretary and to other drug substances as the Secretary may identify.
    ``(4) The provisions of paragraph (1) shall not apply--
            ``(A) to compounded positron emission tomography drugs as 
        defined in section 202(jj); or
            ``(B) to radiopharmaceuticals.''.